Trial Outcomes & Findings for A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis (NCT NCT03227471)
NCT ID: NCT03227471
Last Updated: 2022-01-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
225 participants
Primary outcome timeframe
From first dose of study drug in treatment period up to safety follow-up (up to 28 days)
Results posted on
2022-01-18
Participant Flow
This study included 6 parts: Parts A, B, and C were conducted in healthy adult participants; Part D, E, and F were conducted in adult cystic fibrosis (CF) participants.
Participant milestones
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part D: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Low Dose
Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Medium Dose
Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - High Dose
Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part E: TEZ/IVA
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
|
Part E: VX-445/TEZ/IVA TC
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part F: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
|
Part F: VX-445/TEZ/VX-561 TC
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
30
|
8
|
7
|
25
|
6
|
17
|
12
|
10
|
22
|
21
|
7
|
21
|
8
|
22
|
|
Overall Study
Safety Set
|
9
|
30
|
8
|
7
|
25
|
6
|
17
|
12
|
10
|
22
|
21
|
7
|
21
|
8
|
21
|
|
Overall Study
COMPLETED
|
9
|
30
|
8
|
7
|
24
|
6
|
17
|
12
|
10
|
22
|
21
|
7
|
20
|
8
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part D: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Low Dose
Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Medium Dose
Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - High Dose
Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part E: TEZ/IVA
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
|
Part E: VX-445/TEZ/IVA TC
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part F: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
|
Part F: VX-445/TEZ/VX-561 TC
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Randomized, Never Dosed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=9 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=30 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=8 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=7 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=25 Participants
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=6 Participants
Participants without CF who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=17 Participants
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part D: Placebo
n=12 Participants
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Low Dose
n=10 Participants
Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Medium Dose
n=22 Participants
Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - High Dose
n=21 Participants
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part E: TEZ/IVA
n=7 Participants
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
|
Part E: VX-445/TEZ/IVA TC
n=21 Participants
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part F: Placebo
n=8 Participants
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
|
Part F: VX-445/TEZ/VX-561 TC
n=21 Participants
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
22 Participants
n=62 Participants
|
21 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
21 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
21 Participants
n=24 Participants
|
224 Participants
n=135 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
11 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
58 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=62 Participants
|
10 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
12 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
166 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
22 Participants
n=62 Participants
|
20 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
20 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
20 Participants
n=24 Participants
|
210 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
42 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
22 Participants
n=62 Participants
|
21 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
21 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
20 Participants
n=24 Participants
|
178 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug in treatment period up to safety follow-up (up to 28 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=9 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=30 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=8 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=7 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=25 Participants
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=6 Participants
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=17 Participants
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)Population: The Safety Set will include all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=12 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=53 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=7 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=21 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=8 Participants
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=21 Participants
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
12 Participants
|
49 Participants
|
5 Participants
|
19 Participants
|
7 Participants
|
19 Participants
|
—
|
—
|
|
Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline through Day 29Population: The full analysis set (FAS) included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug in the TC treatment period.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=12 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=10 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=22 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=21 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
0.0 percentage points
Standard Error 2.0
|
11.1 percentage points
Standard Error 2.1
|
7.9 percentage points
Standard Error 1.4
|
13.8 percentage points
Standard Error 1.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=7 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
0.4 percentage points
Standard Error 2.8
|
11.0 percentage points
Standard Error 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=8 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
1.2 percentage points
Standard Error 2.6
|
11.7 percentage points
Standard Error 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dosePopulation: The Pharmacokinetic Set included all participants who received at least 1 dose of study drug and for whom the primary PK data are considered sufficient and interpretable.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=6 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=6 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=6 Participants
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=8 Participants
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=7 Participants
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
n=7 Participants
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Concentration (Cmax) of VX-445
|
0.398 microgram per milliliter
Geometric Coefficient of Variation 23.0
|
0.989 microgram per milliliter
Geometric Coefficient of Variation 35.1
|
2.52 microgram per milliliter
Geometric Coefficient of Variation 13.0
|
4.56 microgram per milliliter
Geometric Coefficient of Variation 28.2
|
7.07 microgram per milliliter
Geometric Coefficient of Variation 19.1
|
0.486 microgram per milliliter
Geometric Coefficient of Variation 27.4
|
1.76 microgram per milliliter
Geometric Coefficient of Variation 14.6
|
0.740 microgram per milliliter
Geometric Coefficient of Variation 27.1
|
SECONDARY outcome
Timeframe: Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dosePopulation: The Pharmacokinetic Set.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=6 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=6 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=6 Participants
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=8 Participants
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=7 Participants
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
n=7 Participants
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
|
11.4 microgram*hour per milliliter
Geometric Coefficient of Variation 34.2
|
30.8 microgram*hour per milliliter
Geometric Coefficient of Variation 21.2
|
87.1 microgram*hour per milliliter
Geometric Coefficient of Variation 39.9
|
125 microgram*hour per milliliter
Geometric Coefficient of Variation 34.2
|
286 microgram*hour per milliliter
Geometric Coefficient of Variation 9.30
|
21.8 microgram*hour per milliliter
Geometric Coefficient of Variation 31.5
|
55.1 microgram*hour per milliliter
Geometric Coefficient of Variation 14.9
|
13.6 microgram*hour per milliliter
Geometric Coefficient of Variation 19.7
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1 and Day 10Population: The Pharmacokinetic Set.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=6 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=6 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Maximum Observed Concentration (Cmax) of VX-445
Day 1
|
1.18 microgram per milliliter
Geometric Coefficient of Variation 19.9
|
2.82 microgram per milliliter
Geometric Coefficient of Variation 25.5
|
3.47 microgram per milliliter
Geometric Coefficient of Variation 52.9
|
9.56 microgram per milliliter
Geometric Coefficient of Variation 65.6
|
—
|
—
|
—
|
—
|
|
Part B: Maximum Observed Concentration (Cmax) of VX-445
Day 10
|
2.13 microgram per milliliter
Geometric Coefficient of Variation 15
|
5.83 microgram per milliliter
Geometric Coefficient of Variation 28.1
|
11.4 microgram per milliliter
Geometric Coefficient of Variation 27.2
|
18.2 microgram per milliliter
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1 and Day 10Population: The Pharmacokinetic Set. Here "Number analyzed" signifies those participants who were evaluated for this outcome measure at specified time points.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=6 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=6 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
Day 1
|
17.9 microgram*hour per milliliter
Geometric Coefficient of Variation 20.0
|
42.2 microgram*hour per milliliter
Geometric Coefficient of Variation 19.5
|
57.9 microgram*hour per milliliter
Geometric Coefficient of Variation 42.8
|
119 microgram*hour per milliliter
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
|
Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
Day 10
|
61.4 microgram*hour per milliliter
Geometric Coefficient of Variation 21.8
|
183 microgram*hour per milliliter
Geometric Coefficient of Variation 32.7
|
452 microgram*hour per milliliter
Geometric Coefficient of Variation 41.5
|
692 microgram*hour per milliliter
Geometric Coefficient of Variation 47.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 10Population: The Pharmacokinetic Set.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=6 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=6 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445
|
1.05 microgram per milliliter
Geometric Coefficient of Variation 24.5
|
2.81 microgram per milliliter
Geometric Coefficient of Variation 33.2
|
7.10 microgram per milliliter
Geometric Coefficient of Variation 30.1
|
11.5 microgram per milliliter
Geometric Coefficient of Variation 32.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14Population: The Pharmacokinetic Set. Here "Number analyzed" signified those subjects who were evaluated at specified time points.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 1
|
3.04 microgram per milliliter
Geometric Coefficient of Variation 23.2
|
4.86 microgram per milliliter
Geometric Coefficient of Variation 25.4
|
1.72 microgram per milliliter
Geometric Coefficient of Variation 16.5
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 7
|
8.29 microgram per milliliter
Geometric Coefficient of Variation 31.9
|
10.3 microgram per milliliter
Geometric Coefficient of Variation 18.4
|
3.58 microgram per milliliter
Geometric Coefficient of Variation 14.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 14
|
8.71 microgram per milliliter
Geometric Coefficient of Variation 9.65
|
14.0 microgram per milliliter
Geometric Coefficient of Variation 19.2
|
4.73 microgram per milliliter
Geometric Coefficient of Variation 15.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 1
|
3.81 microgram per milliliter
Geometric Coefficient of Variation 16.4
|
5.67 microgram per milliliter
Geometric Coefficient of Variation 17.2
|
5.38 microgram per milliliter
Geometric Coefficient of Variation 19.2
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 7
|
7.09 microgram per milliliter
Geometric Coefficient of Variation 19.4
|
8.29 microgram per milliliter
Geometric Coefficient of Variation 13.6
|
7.01 microgram per milliliter
Geometric Coefficient of Variation 14.7
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 14
|
8.11 microgram per milliliter
Geometric Coefficient of Variation 21.2
|
9.07 microgram per milliliter
Geometric Coefficient of Variation 7.60
|
8.60 microgram per milliliter
Geometric Coefficient of Variation 12.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 1
|
0.929 microgram per milliliter
Geometric Coefficient of Variation 35
|
0.988 microgram per milliliter
Geometric Coefficient of Variation 31.7
|
1.30 microgram per milliliter
Geometric Coefficient of Variation 17.3
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 7
|
4.34 microgram per milliliter
Geometric Coefficient of Variation 28.7
|
5.19 microgram per milliliter
Geometric Coefficient of Variation 16.8
|
5.86 microgram per milliliter
Geometric Coefficient of Variation 11.3
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 14
|
5.77 microgram per milliliter
Geometric Coefficient of Variation 24.6
|
6.79 microgram per milliliter
Geometric Coefficient of Variation 14.9
|
7.54 microgram per milliliter
Geometric Coefficient of Variation 11.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 1
|
0.553 microgram per milliliter
Geometric Coefficient of Variation 47.0
|
0.667 microgram per milliliter
Geometric Coefficient of Variation 39.6
|
0.716 microgram per milliliter
Geometric Coefficient of Variation 17.0
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 7
|
4.72 microgram per milliliter
Geometric Coefficient of Variation 30.3
|
6.41 microgram per milliliter
Geometric Coefficient of Variation 33.2
|
5.46 microgram per milliliter
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 14
|
7.69 microgram per milliliter
Geometric Coefficient of Variation 23.7
|
10.1 microgram per milliliter
Geometric Coefficient of Variation 24.2
|
7.93 microgram per milliliter
Geometric Coefficient of Variation 28.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14Population: The Pharmacokinetic Set. Here "Number analyzed" signified those subjects who were evaluated at specified time points.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 1
|
48.6 microgram*hour per milliliter
Geometric Coefficient of Variation 22.7
|
72.5 microgram*hour per milliliter
Geometric Coefficient of Variation 20.7
|
26.4 microgram*hour per milliliter
Geometric Coefficient of Variation 13.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 7
|
156 microgram*hour per milliliter
Geometric Coefficient of Variation 37.1
|
177 microgram*hour per milliliter
Geometric Coefficient of Variation 30.0
|
65.4 microgram*hour per milliliter
Geometric Coefficient of Variation 20.7
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 14
|
345 microgram*hour per milliliter
Geometric Coefficient of Variation 30.7
|
506 microgram*hour per milliliter
Geometric Coefficient of Variation 31.5
|
183 microgram*hour per milliliter
Geometric Coefficient of Variation 18.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 1
|
41.4 microgram*hour per milliliter
Geometric Coefficient of Variation 27.5
|
43.8 microgram*hour per milliliter
Geometric Coefficient of Variation 9.91
|
42.7 microgram*hour per milliliter
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 7
|
103 microgram*hour per milliliter
Geometric Coefficient of Variation 35.8
|
105 microgram*hour per milliliter
Geometric Coefficient of Variation 16.5
|
96.9 microgram*hour per milliliter
Geometric Coefficient of Variation 18.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 14
|
252 microgram*hour per milliliter
Geometric Coefficient of Variation 35.1
|
288 microgram*hour per milliliter
Geometric Coefficient of Variation 13.6
|
275 microgram*hour per milliliter
Geometric Coefficient of Variation 19.5
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 1
|
17.7 microgram*hour per milliliter
Geometric Coefficient of Variation 37.2
|
20.1 microgram*hour per milliliter
Geometric Coefficient of Variation 35.2
|
25.5 microgram*hour per milliliter
Geometric Coefficient of Variation 19.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 7
|
90.9 microgram*hour per milliliter
Geometric Coefficient of Variation 29.9
|
110 microgram*hour per milliliter
Geometric Coefficient of Variation 17.8
|
125 microgram*hour per milliliter
Geometric Coefficient of Variation 14.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 14
|
380 microgram*hour per milliliter
Geometric Coefficient of Variation 22.1
|
477 microgram*hour per milliliter
Geometric Coefficient of Variation 16.0
|
512 microgram*hour per milliliter
Geometric Coefficient of Variation 17.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 1
|
6.65 microgram*hour per milliliter
Geometric Coefficient of Variation 48.6
|
8.19 microgram*hour per milliliter
Geometric Coefficient of Variation 52.5
|
9.00 microgram*hour per milliliter
Geometric Coefficient of Variation 16.6
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 7
|
108 microgram*hour per milliliter
Geometric Coefficient of Variation 31.2
|
143 microgram*hour per milliliter
Geometric Coefficient of Variation 34.1
|
123 microgram*hour per milliliter
Geometric Coefficient of Variation 28.7
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 14
|
617 microgram*hour per milliliter
Geometric Coefficient of Variation 23.2
|
831 microgram*hour per milliliter
Geometric Coefficient of Variation 29.5
|
652 microgram*hour per milliliter
Geometric Coefficient of Variation 31.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14Population: The Pharmacokinetic Set. Here "Number analyzed" signified those subjects who were evaluated at specified time points.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 1
|
425 nanogram per milliliter
Geometric Coefficient of Variation 29.8
|
461 nanogram per milliliter
Geometric Coefficient of Variation 49.3
|
437 nanogram per milliliter
Geometric Coefficient of Variation 9.63
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 7
|
1290 nanogram per milliliter
Geometric Coefficient of Variation 41.1
|
1190 nanogram per milliliter
Geometric Coefficient of Variation 42.4
|
1070 nanogram per milliliter
Geometric Coefficient of Variation 20.0
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 14
|
1360 nanogram per milliliter
Geometric Coefficient of Variation 21.9
|
1920 nanogram per milliliter
Geometric Coefficient of Variation 33.7
|
1410 nanogram per milliliter
Geometric Coefficient of Variation 25.5
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 1
|
1250 nanogram per milliliter
Geometric Coefficient of Variation 29.9
|
1190 nanogram per milliliter
Geometric Coefficient of Variation 28.1
|
1070 nanogram per milliliter
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 7
|
2460 nanogram per milliliter
Geometric Coefficient of Variation 26.8
|
2590 nanogram per milliliter
Geometric Coefficient of Variation 28.1
|
2070 nanogram per milliliter
Geometric Coefficient of Variation 23.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 14
|
2680 nanogram per milliliter
Geometric Coefficient of Variation 19.4
|
3900 nanogram per milliliter
Geometric Coefficient of Variation 21.4
|
2990 nanogram per milliliter
Geometric Coefficient of Variation 28.3
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 1
|
901 nanogram per milliliter
Geometric Coefficient of Variation 38.2
|
1180 nanogram per milliliter
Geometric Coefficient of Variation 16.6
|
631 nanogram per milliliter
Geometric Coefficient of Variation 31.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 7
|
1960 nanogram per milliliter
Geometric Coefficient of Variation 38.1
|
2590 nanogram per milliliter
Geometric Coefficient of Variation 7.3
|
1400 nanogram per milliliter
Geometric Coefficient of Variation 29.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 14
|
2060 nanogram per milliliter
Geometric Coefficient of Variation 30.1
|
3350 nanogram per milliliter
Geometric Coefficient of Variation 17.4
|
1980 nanogram per milliliter
Geometric Coefficient of Variation 34.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14Population: The Pharmacokinetic Set. Here "Number analyzed" signified those subjects who were evaluated at specified time points.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 1
|
6350 nanogram*hour per milliliter
Geometric Coefficient of Variation 40.9
|
6210 nanogram*hour per milliliter
Geometric Coefficient of Variation 45.5
|
5480 nanogram*hour per milliliter
Geometric Coefficient of Variation 28.5
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 7
|
21600 nanogram*hour per milliliter
Geometric Coefficient of Variation 65.6
|
18800 nanogram*hour per milliliter
Geometric Coefficient of Variation 50.7
|
16900 nanogram*hour per milliliter
Geometric Coefficient of Variation 28.4
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 14
|
27900 nanogram*hour per milliliter
Geometric Coefficient of Variation 48.7
|
35000 nanogram*hour per milliliter
Geometric Coefficient of Variation 44.8
|
32600 nanogram*hour per milliliter
Geometric Coefficient of Variation 40.6
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 1
|
16900 nanogram*hour per milliliter
Geometric Coefficient of Variation 38.9
|
14800 nanogram*hour per milliliter
Geometric Coefficient of Variation 32.3
|
13300 nanogram*hour per milliliter
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 7
|
47500 nanogram*hour per milliliter
Geometric Coefficient of Variation 43.6
|
46300 nanogram*hour per milliliter
Geometric Coefficient of Variation 30.6
|
36400 nanogram*hour per milliliter
Geometric Coefficient of Variation 25.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 14
|
75300 nanogram*hour per milliliter
Geometric Coefficient of Variation 42.7
|
97000 nanogram*hour per milliliter
Geometric Coefficient of Variation 31.3
|
86100 nanogram*hour per milliliter
Geometric Coefficient of Variation 30.2
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 1
|
11100 nanogram*hour per milliliter
Geometric Coefficient of Variation 49.9
|
14100 nanogram*hour per milliliter
Geometric Coefficient of Variation 20.3
|
9050 nanogram*hour per milliliter
Geometric Coefficient of Variation 26.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 7
|
39700 nanogram*hour per milliliter
Geometric Coefficient of Variation 38.8
|
51400 nanogram*hour per milliliter
Geometric Coefficient of Variation 13.0
|
29100 nanogram*hour per milliliter
Geometric Coefficient of Variation 36.0
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 14
|
66300 nanogram*hour per milliliter
Geometric Coefficient of Variation 44.9
|
123000 nanogram*hour per milliliter
Geometric Coefficient of Variation 23.1
|
67100 nanogram*hour per milliliter
Geometric Coefficient of Variation 42.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 7 and Day 14Population: The Pharmacokinetic Set.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 7
|
4.63 microgram per milliliter
Geometric Coefficient of Variation 46.8
|
5.91 microgram per milliliter
Geometric Coefficient of Variation 35.5
|
2.09 microgram per milliliter
Geometric Coefficient of Variation 14.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
VX-445: Day 14
|
4.45 microgram per milliliter
Geometric Coefficient of Variation 38.9
|
7.60 microgram per milliliter
Geometric Coefficient of Variation 29.8
|
2.92 microgram per milliliter
Geometric Coefficient of Variation 13.2
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 7
|
2.73 microgram per milliliter
Geometric Coefficient of Variation 48.7
|
2.77 microgram per milliliter
Geometric Coefficient of Variation 19.2
|
2.52 microgram per milliliter
Geometric Coefficient of Variation 23.0
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
TEZ: Day 14
|
3.10 microgram per milliliter
Geometric Coefficient of Variation 33.4
|
3.70 microgram per milliliter
Geometric Coefficient of Variation 16.0
|
3.62 microgram per milliliter
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 7
|
3.36 microgram per milliliter
Geometric Coefficient of Variation 27.1
|
3.98 microgram per milliliter
Geometric Coefficient of Variation 16.8
|
4.71 microgram per milliliter
Geometric Coefficient of Variation 14.0
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M1-TEZ: Day 14
|
4.38 microgram per milliliter
Geometric Coefficient of Variation 20.5
|
5.42 microgram per milliliter
Geometric Coefficient of Variation 16.1
|
5.52 microgram per milliliter
Geometric Coefficient of Variation 12.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 7
|
4.06 microgram per milliliter
Geometric Coefficient of Variation 32.8
|
5.63 microgram per milliliter
Geometric Coefficient of Variation 37.5
|
4.92 microgram per milliliter
Geometric Coefficient of Variation 27.7
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
M2-TEZ: Day 14
|
6.46 microgram per milliliter
Geometric Coefficient of Variation 22.5
|
8.85 microgram per milliliter
Geometric Coefficient of Variation 29.9
|
7.38 microgram per milliliter
Geometric Coefficient of Variation 29.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 7 and Day 14Population: The Pharmacokinetic Set.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=5 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=6 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=6 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 7
|
753 nanogram per milliliter
Geometric Coefficient of Variation 75
|
759 nanogram per milliliter
Geometric Coefficient of Variation 45.7
|
604 nanogram per milliliter
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
IVA: Day 14
|
610 nanogram per milliliter
Geometric Coefficient of Variation 55.6
|
990 nanogram per milliliter
Geometric Coefficient of Variation 43.4
|
881 nanogram per milliliter
Geometric Coefficient of Variation 35.3
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 7
|
1790 nanogram per milliliter
Geometric Coefficient of Variation 43.7
|
1960 nanogram per milliliter
Geometric Coefficient of Variation 21.4
|
1400 nanogram per milliliter
Geometric Coefficient of Variation 21.3
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M1-IVA: Day 14
|
1600 nanogram per milliliter
Geometric Coefficient of Variation 46.2
|
2210 nanogram per milliliter
Geometric Coefficient of Variation 19.8
|
1930 nanogram per milliliter
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 7
|
1530 nanogram per milliliter
Geometric Coefficient of Variation 31.5
|
2260 nanogram per milliliter
Geometric Coefficient of Variation 11.9
|
1270 nanogram per milliliter
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
M6-IVA: Day 14
|
1360 nanogram per milliliter
Geometric Coefficient of Variation 49.1
|
2600 nanogram per milliliter
Geometric Coefficient of Variation 18.0
|
1640 nanogram per milliliter
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 and Day 29Population: FAS. Here "number analyzed" signifies those participants who were evaluated at specified time points for this outcome measure.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=10 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=21 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
VX-445: Day 15
|
1.04 microgram per milliliter
Standard Deviation 0.612
|
2.15 microgram per milliliter
Standard Deviation 0.977
|
5.77 microgram per milliliter
Standard Deviation 4.14
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
VX-445: Day 29
|
1.27 microgram per milliliter
Standard Deviation 0.530
|
2.18 microgram per milliliter
Standard Deviation 1.26
|
5.57 microgram per milliliter
Standard Deviation 2.80
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
TEZ: Day 15
|
1.85 microgram per milliliter
Standard Deviation 1.26
|
1.68 microgram per milliliter
Standard Deviation 0.700
|
1.76 microgram per milliliter
Standard Deviation 0.960
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
TEZ: Day 29
|
2.16 microgram per milliliter
Standard Deviation 1.27
|
1.77 microgram per milliliter
Standard Deviation 0.833
|
2.22 microgram per milliliter
Standard Deviation 1.62
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
M1-TEZ: Day 15
|
4.46 microgram per milliliter
Standard Deviation 1.96
|
4.11 microgram per milliliter
Standard Deviation 1.47
|
4.43 microgram per milliliter
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
M1-TEZ: Day 29
|
4.77 microgram per milliliter
Standard Deviation 2.04
|
4.30 microgram per milliliter
Standard Deviation 1.55
|
4.74 microgram per milliliter
Standard Deviation 1.89
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
IVA: Day 15
|
0.720 microgram per milliliter
Standard Deviation 0.484
|
0.665 microgram per milliliter
Standard Deviation 0.414
|
0.701 microgram per milliliter
Standard Deviation 0.593
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
IVA: Day 29
|
0.753 microgram per milliliter
Standard Deviation 0.424
|
0.704 microgram per milliliter
Standard Deviation 0.414
|
0.658 microgram per milliliter
Standard Deviation 0.386
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
M1-IVA: Day 15
|
1.29 microgram per milliliter
Standard Deviation 0.748
|
1.21 microgram per milliliter
Standard Deviation 0.666
|
1.45 microgram per milliliter
Standard Deviation 1.22
|
—
|
—
|
—
|
—
|
—
|
|
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
M1-IVA: Day 29
|
1.57 microgram per milliliter
Standard Deviation 0.830
|
1.20 microgram per milliliter
Standard Deviation 0.717
|
1.29 microgram per milliliter
Standard Deviation 0.797
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 and Day 29Population: FAS. Here "Number analyzed" signifies those participants who were evaluated at specified time points for this outcome measure.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=7 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
VX-445: Day 15
|
—
|
5.07 microgram per milliliter
Standard Deviation 2.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
VX-445: Day 29
|
—
|
5.35 microgram per milliliter
Standard Deviation 3.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
TEZ: Day 15
|
1.85 microgram per milliliter
Standard Deviation 0.863
|
1.86 microgram per milliliter
Standard Deviation 1.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
TEZ: Day 29
|
1.84 microgram per milliliter
Standard Deviation 1.28
|
1.99 microgram per milliliter
Standard Deviation 1.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
M1-TEZ: Day 15
|
3.96 microgram per milliliter
Standard Deviation 1.76
|
4.57 microgram per milliliter
Standard Deviation 1.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
M1-TEZ: Day 29
|
3.73 microgram per milliliter
Standard Deviation 1.51
|
4.71 microgram per milliliter
Standard Deviation 1.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
IVA: Day 15
|
0.766 microgram per milliliter
Standard Deviation 0.366
|
0.659 microgram per milliliter
Standard Deviation 0.529
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
IVA: Day 29
|
0.595 microgram per milliliter
Standard Deviation 0.303
|
0.798 microgram per milliliter
Standard Deviation 0.901
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
M1-IVA: Day 15
|
1.22 microgram per milliliter
Standard Deviation 0.470
|
1.09 microgram per milliliter
Standard Deviation 0.973
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
M1-IVA: Day 29
|
0.943 microgram per milliliter
Standard Deviation 0.431
|
1.43 microgram per milliliter
Standard Deviation 1.54
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 and Day 29Population: FAS. Here, "Number analyzed" signifies those participants who were evaluated at specified time points for this outcome measure.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=20 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
VX-445: Day 15
|
4.40 microgram per milliliter
Standard Deviation 1.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
VX-445: Day 29
|
5.25 microgram per milliliter
Standard Deviation 2.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
TEZ: Day 15
|
1.80 microgram per milliliter
Standard Deviation 0.658
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
TEZ: Day 29
|
2.22 microgram per milliliter
Standard Deviation 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
M1-TEZ: Day 15
|
4.99 microgram per milliliter
Standard Deviation 1.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
M1-TEZ: Day 29
|
5.09 microgram per milliliter
Standard Deviation 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
VX-561: Day 15
|
0.441 microgram per milliliter
Standard Deviation 0.174
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
VX-561: Day 29
|
0.597 microgram per milliliter
Standard Deviation 0.473
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=12 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=10 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=22 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=21 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part D: Absolute Change in Sweat Chloride Concentration
|
-2.2 millimole per liter (mmol/L)
Standard Error 3.9
|
-38.2 millimole per liter (mmol/L)
Standard Error 4.2
|
-33.2 millimole per liter (mmol/L)
Standard Error 2.8
|
-39.1 millimole per liter (mmol/L)
Standard Error 2.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=7 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part E: Absolute Change in Sweat Chloride Concentration
|
0.8 mmol/L
Standard Error 4.9
|
-39.6 mmol/L
Standard Error 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=8 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part F: Absolute Change in Sweat Chloride Concentration
|
1.0 mmol/L
Standard Error 4.6
|
-33.6 mmol/L
Standard Error 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=12 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=10 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=22 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=21 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part D: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
0.3 percent change
Standard Error 4.0
|
19.3 percent change
Standard Error 4.2
|
13.8 percent change
Standard Error 2.8
|
26.2 percent change
Standard Error 2.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=7 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part E: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
1.4 percent change
Standard Error 5.0
|
19.2 percent change
Standard Error 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=8 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part F: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
1.6 percent change
Standard Error 4.6
|
19.9 percent change
Standard Error 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=12 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=10 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=22 Participants
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=21 Participants
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
|
4.2 units on a scale
Standard Error 4.9
|
20.8 units on a scale
Standard Error 5.4
|
15.4 units on a scale
Standard Error 3.7
|
25.7 units on a scale
Standard Error 3.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=7 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
|
5.2 units on a scale
Standard Error 7.1
|
20.7 units on a scale
Standard Error 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Day 29Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=8 Participants
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=21 Participants
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part A: VX-445 (Cohort A7-IV)
Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.
|
|---|---|---|---|---|---|---|---|---|
|
Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
|
20.2 units on a scale
Standard Error 6.9
|
20.2 units on a scale
Standard Error 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Pooled Placebo (Except Cohort A7)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: VX-445 (Except Cohort A7)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: VX-445 (Cohort A7)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Pooled Placebo (Cohort B1 to B4)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: VX-445 (Cohort B1 to B4)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: Pooled Placebo (Cohort C1 to C3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part D: Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Part D: VX-445/TEZ/IVA TC - Low Dose
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part D: VX-445/TEZ/IVA TC - Medium Dose
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Part D: VX-445/TEZ/IVA TC - High Dose
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part E: TEZ/IVA
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part E: VX-445/TEZ/IVA TC
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part F: Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part F: VX-445/TEZ/VX-561 TC
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=9 participants at risk
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=30 participants at risk
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=8 participants at risk
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=7 participants at risk
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=25 participants at risk
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=6 participants at risk
Participants without CF who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=17 participants at risk
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part D: Placebo
n=12 participants at risk
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Low Dose
n=10 participants at risk
Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Medium Dose
n=22 participants at risk
Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - High Dose
n=21 participants at risk
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part E: TEZ/IVA
n=7 participants at risk
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
|
Part E: VX-445/TEZ/IVA TC
n=21 participants at risk
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part F: Placebo
n=8 participants at risk
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
|
Part F: VX-445/TEZ/VX-561 TC
n=21 participants at risk
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.1%
2/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Jugular vein thrombosis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
Other adverse events
| Measure |
Part A: Pooled Placebo (Except Cohort A7)
n=9 participants at risk
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
|
Part A: VX-445 (Except Cohort A7)
n=30 participants at risk
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.
|
Part A: VX-445 (Cohort A7)
n=8 participants at risk
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.
|
Part B: Pooled Placebo (Cohort B1 to B4)
n=7 participants at risk
Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.
|
Part B: VX-445 (Cohort B1 to B4)
n=25 participants at risk
Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
|
Part C: Pooled Placebo (Cohort C1 to C3)
n=6 participants at risk
Participants without CF who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 14 days.
|
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
n=17 participants at risk
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
|
Part D: Placebo
n=12 participants at risk
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Low Dose
n=10 participants at risk
Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - Medium Dose
n=22 participants at risk
Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part D: VX-445/TEZ/IVA TC - High Dose
n=21 participants at risk
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part E: TEZ/IVA
n=7 participants at risk
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
|
Part E: VX-445/TEZ/IVA TC
n=21 participants at risk
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
|
Part F: Placebo
n=8 participants at risk
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
|
Part F: VX-445/TEZ/VX-561 TC
n=21 participants at risk
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
3.3%
1/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
1/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
13.6%
3/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
3.3%
1/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
1/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
2/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
13.6%
3/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
37.5%
3/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.0%
1/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.0%
1/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
25.0%
2/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
3.3%
1/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Catheter site pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Infusion site pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Fatigue
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
33.3%
4/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
19.0%
4/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.0%
1/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
11.8%
2/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
2/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.1%
2/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
1/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
11.8%
2/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
1/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
5.9%
1/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
40.0%
4/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
22.7%
5/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
33.3%
7/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
33.3%
7/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
25.0%
2/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
23.8%
5/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
25.0%
3/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
30.0%
3/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
18.2%
4/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
23.8%
5/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
38.1%
8/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
2/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
22.7%
5/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
2/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.1%
2/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
25.0%
2/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
23.8%
5/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
16.7%
2/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.1%
2/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
13.6%
3/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
19.0%
4/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
22.7%
5/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Malaise
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Chest pain
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Chills
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.5%
1/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
19.0%
4/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
1/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Eye disorders
Visual impairment
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
8.3%
1/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
12.5%
1/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
33.3%
4/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
20.0%
2/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
18.2%
4/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.5%
2/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
23.8%
5/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
37.5%
3/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
14.3%
3/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
10.0%
1/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
4.8%
1/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/30 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/25 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/6 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/17 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/12 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/10 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
9.1%
2/22 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/7 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/8 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
0.00%
0/21 • Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place