Trial Outcomes & Findings for Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation (NCT NCT01225211)
NCT ID: NCT01225211
Last Updated: 2015-10-05
Results Overview
AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
312 participants
Primary outcome timeframe
Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)
Results posted on
2015-10-05
Participant Flow
Participants in each cohort are mutually exclusive. A total of 312 participants were randomized of which one participant did not receive any treatment and a total of 311 participants were treated.
Study included 4 cohorts which were studied in sequential manner. For results reporting, combined placebo arm was reported for Cohort 2 and 3 and results for these 2 cohorts are reported collectively.
Participant milestones
| Measure |
Cohort 1: Placebo
Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
|
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
27
|
23
|
21
|
42
|
11
|
63
|
62
|
|
Overall Study
COMPLETED
|
21
|
20
|
20
|
27
|
23
|
21
|
41
|
11
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
5
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
|
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE)
n=27 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
n=23 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
n=42 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 4: Placebo
n=63 Participants
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
|
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
n=62 Participants
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
63 Participants
n=6 Participants
|
62 Participants
n=64 Participants
|
311 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
29 Participants
n=64 Participants
|
144 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
33 Participants
n=64 Participants
|
167 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)Population: Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=41 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)
Participants with SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)
Participants with any AEs
|
12 participants
|
29 participants
|
15 participants
|
14 participants
|
12 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)Population: Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=27 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=23 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=42 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
n=38 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)
Participants with any AEs
|
23 participants
|
18 participants
|
18 participants
|
37 participants
|
7 participants
|
20 participants
|
12 participants
|
15 participants
|
26 participants
|
10 participants
|
|
Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)
Participants with SAEs
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
2 participants
|
4 participants
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)Population: Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.
AEs and SAEs are defined in Outcome Measure 1.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=63 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=62 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs
Participants with any AEs
|
53 participants
|
52 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs
Participants with SAEs
|
5 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1: Day 14, Day 21Population: Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=19 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=14 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21
|
-2.131 millimole per liter (mmol/L)
Interval -5.381 to 1.119
|
-9.128 millimole per liter (mmol/L)
Interval -12.893 to -5.362
|
0.548 millimole per liter (mmol/L)
Interval -2.955 to 4.052
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 2 and 3: Day 28, Day 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=19 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=9 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=24 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56
|
0.321 mmol/L
Interval -4.208 to 4.849
|
-1.043 mmol/L
Interval -5.8 to 3.714
|
-2.900 mmol/L
Interval -7.542 to 1.743
|
-1.240 mmol/L
Interval -6.287 to 3.807
|
-2.154 mmol/L
Interval -9.177 to 4.87
|
1.627 mmol/L
Interval -2.661 to 5.915
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=60 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=55 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56
|
-1.23 percent predicted of FEV1
Standard Error 0.801
|
-0.62 percent predicted of FEV1
Standard Error 0.829
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Baseline, Day 14Population: Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=36 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14
|
-4.442 mmol/L
Interval -7.141 to -1.742
|
-1.668 mmol/L
Interval -5.606 to 2.271
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Baseline, Day 14Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=19 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=25 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14
|
-6.490 mmol/L
Interval -11.226 to -1.755
|
-5.901 mmol/L
Interval -10.91 to -0.892
|
-9.442 mmol/L
Interval -13.953 to -4.931
|
-3.137 mmol/L
Interval -8.167 to 1.893
|
-9.179 mmol/L
Interval -15.47 to -2.888
|
0.048 mmol/L
Interval -4.162 to 4.258
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=59 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=54 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56
|
-0.78 mmol/L
Standard Error 1.230
|
-11.82 mmol/L
Standard Error 1.281
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 14, Day 21Population: Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=18 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21
|
0.128 liters
Interval 0.03 to 0.225
|
0.015 liters
Interval -0.094 to 0.124
|
-0.046 liters
Interval -0.138 to 0.047
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 14, Day 21Population: Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=18 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21
|
3.46 percent predicted of FEV1
Interval 0.87 to 6.05
|
0.63 percent predicted of FEV1
Interval -2.2 to 3.46
|
-1.44 percent predicted of FEV1
Interval -3.89 to 1.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 and 3: Day 28, Day 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=10 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56
|
1.96 percent predicted of FEV1
Interval -0.84 to 4.76
|
1.99 percent predicted of FEV1
Interval -0.87 to 4.84
|
6.15 percent predicted of FEV1
Interval 3.27 to 9.02
|
2.29 percent predicted of FEV1
Interval -0.82 to 5.39
|
6.09 percent predicted of FEV1
Interval 2.02 to 10.16
|
-1.57 percent predicted of FEV1
Interval -4.24 to 1.09
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 and 3: Day 28, Day 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=10 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=24 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56
|
3.13 percent change
Interval -1.29 to 7.54
|
2.98 percent change
Interval -1.52 to 7.48
|
9.70 percent change
Interval 5.17 to 14.23
|
4.30 percent change
Interval -0.59 to 9.19
|
8.24 percent change
Interval 1.83 to 14.65
|
-2.05 percent change
Interval -6.25 to 2.15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 and 3: Baseline, Day 28 and 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=23 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56
Day 28: (n= 21, 20, 20, 18, 11, 27)
|
0.21 percent predicted of FEV1
Interval -2.77 to 3.19
|
-1.35 percent predicted of FEV1
Interval -4.39 to 1.69
|
-2.62 percent predicted of FEV1
Interval -5.67 to 0.42
|
-3.82 percent predicted of FEV1
Interval -7.03 to -0.61
|
-4.52 percent predicted of FEV1
Interval -8.65 to -0.39
|
-0.03 percent predicted of FEV1
Interval -2.68 to 2.62
|
—
|
—
|
—
|
—
|
|
Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56
Day 56: (n= 21, 20, 20, 17, 10, 24)
|
1.82 percent predicted of FEV1
Interval -1.28 to 4.91
|
0.64 percent predicted of FEV1
Interval -2.52 to 3.8
|
3.59 percent predicted of FEV1
Interval 0.41 to 6.77
|
-1.68 percent predicted of FEV1
Interval -5.12 to 1.75
|
2.16 percent predicted of FEV1
Interval -2.34 to 6.66
|
-2.02 percent predicted of FEV1
Interval -4.97 to 0.93
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 and 3: Baseline, Day 28 and 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=23 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=11 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56
Day 28: (n= 21, 20, 20, 18, 11, 27)
|
0.24 percent change
Interval -4.27 to 4.75
|
-1.15 percent change
Interval -5.75 to 3.45
|
-3.13 percent change
Interval -7.74 to 1.48
|
-5.46 percent change
Interval -10.32 to -0.6
|
-6.39 percent change
Interval -12.65 to -0.14
|
1.89 percent change
Interval -2.12 to 5.9
|
—
|
—
|
—
|
—
|
|
Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56
Day 56: (n= 21, 20, 20, 17, 10, 24)
|
2.51 percent change
Interval -2.21 to 7.23
|
1.72 percent change
Interval -3.09 to 6.53
|
5.55 percent change
Interval 0.7 to 10.39
|
-2.34 percent change
Interval -7.57 to 2.89
|
2.96 percent change
Interval -3.9 to 9.81
|
-2.42 percent change
Interval -6.91 to 2.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=60 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=55 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56
|
-2.20 percent change
Standard Error 1.373
|
-0.69 percent change
Standard Error 1.423
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2 and 3: Day 28, Day 56Population: Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=21 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=20 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=17 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=10 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=25 Participants
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56
|
3.3 units on a scale
Interval -3.6 to 10.1
|
7.9 units on a scale
Interval 0.8 to 14.9
|
8.9 units on a scale
Interval 1.9 to 15.9
|
5.5 units on a scale
Interval -2.1 to 13.1
|
11.2 units on a scale
Interval 1.3 to 21.1
|
-8.6 units on a scale
Interval -14.9 to -2.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
CFQ-R respiratory domain is defined in Outcome Measure 17.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=60 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=55 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56
|
-0.82 units on a scale
Standard Error 1.802
|
5.66 units on a scale
Standard Error 1.864
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
BMI was defined as weight in kilogram (kg) divided by height\*height in square meter (m\^2).
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=60 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=56 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56
|
0.08 kg/m^2
Standard Error 0.075
|
-0.04 kg/m^2
Standard Error 0.077
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 4: Baseline, Day 56Population: Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1: Placebo - Period 1
n=60 Participants
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd - Period 1
n=56 Participants
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 4: Absolute Change From Baseline in Weight at Day 56
|
0.16 kg
Standard Error 0.211
|
-0.11 kg
Standard Error 0.216
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: LUM 200 mg qd - Period 1
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1: Placebo - Period 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1: Placebo - Period 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2: LUM 200 mg qd - Period 1
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 2: LUM 400 mg qd - Period 1
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 2: LUM 600 mg qd - Period 1
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Cohort 3: LUM 400 mg q12h - Period 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 and 3: Placebo (HO and HE) - Period 1
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: LUM 200 mg qd - Period 1
n=41 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: Placebo - Period 1
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 2: LUM 200 mg qd - Period 1
n=23 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 2: LUM 400 mg qd - Period 1
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 2: LUM 600 mg qd - Period 1
n=42 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 3: LUM 400 mg q12h - Period 1
n=11 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 1
n=27 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
n=38 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
n=11 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 4: Placebo
n=63 participants at risk
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
|
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
n=62 participants at risk
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.3%
7/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Spirometry abnormal
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Congenital, familial and genetic disorders
CYSTIC FIBROSIS LUNG
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
3/38 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.8%
4/27 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATION ABNORMAL
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
Other adverse events
| Measure |
Cohort 1: LUM 200 mg qd - Period 1
n=41 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
|
Cohort 1: LUM 200 mg qd+IVA 150 mg q12h - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: LUM 200 mg qd+IVA 250 mg q12h - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
|
Cohort 1: Placebo - Period 1
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
|
Cohort 1: Placebo - Period 2
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
|
Cohort 2: LUM 200 mg qd - Period 1
n=23 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 2: LUM 400 mg qd - Period 1
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 2: LUM 600 mg qd - Period 1
n=42 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
|
Cohort 3: LUM 400 mg q12h - Period 1
n=11 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 1
n=27 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
|
Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) - Period 2
n=21 participants at risk
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) - Period 2
n=20 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) - Period 2
n=38 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) - Period 2
n=11 participants at risk
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
|
Cohort 2 and 3: Placebo (HO and HE) - Period 2
n=27 participants at risk
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
|
Cohort 4: Placebo
n=63 participants at risk
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
|
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
n=62 participants at risk
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.6%
6/41 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
20.0%
4/20 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
4/21 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
13.0%
3/23 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
38.1%
8/21 • Number of events 8 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
28.6%
12/42 • Number of events 13 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
22.2%
6/27 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
25.0%
5/20 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
13.2%
5/38 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
27.3%
3/11 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
22.2%
6/27 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
12/63 • Number of events 15 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
21.0%
13/62 • Number of events 16 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
7.3%
3/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.7%
2/23 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
6/42 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.5%
5/27 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.7%
2/23 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
20.0%
4/20 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
5/63 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
15.0%
3/20 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
3/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
15.0%
3/20 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.1%
5/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
3/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.3%
3/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
23.8%
10/42 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.5%
9/62 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATION ABNORMAL
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
16.7%
7/42 • Number of events 8 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
9/63 • Number of events 9 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
27.4%
17/62 • Number of events 20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
LUNG HYPERINFLATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
6/63 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.1%
5/62 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL SECRETION RETENTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED VISCOSITY OF BRONCHIAL SECRETION
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL MUCOSAL DISORDER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL OEDEMA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PROLONGED EXPIRATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
RHONCHI
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.1%
3/42 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
17.4%
4/23 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
3/38 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
7/63 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.1%
5/62 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
3/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISCOLOURED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PAINFUL RESPIRATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
12/63 • Number of events 12 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
16.1%
10/62 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL OEDEMA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
SINUS HEADACHE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
TREMOR
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
TUNNEL VISION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
HEADACHE
|
9.8%
4/41 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
4/21 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
23.8%
5/21 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
4/21 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
4/42 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.5%
5/27 • Number of events 9 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.4%
7/38 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.5%
5/27 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
17.5%
11/63 • Number of events 18 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.9%
5/42 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
5/63 • Number of events 9 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.3%
7/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.3%
3/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.7%
2/23 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
7/63 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.1%
5/62 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.4%
1/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
NAUSEA
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
19.0%
8/42 • Number of events 8 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
3/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
3/38 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
7/63 • Number of events 9 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.3%
7/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
FLATULENCE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.1%
3/42 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.1%
5/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
DISTAL ILEAL OBSTRUCTION SYNDROME
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
FAECAL VOLUME INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
LIP SWELLING
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
POST-TUSSIVE VOMITING
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Gastrointestinal disorders
STEATORRHOEA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
FATIGUE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.1%
3/42 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
6/63 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
PYREXIA
|
7.3%
3/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
6/42 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.1%
3/27 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
9/63 • Number of events 10 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.3%
7/62 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
PAIN
|
7.3%
3/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
APPLICATION SITE PRURITUS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
CATHETER SITE PAIN
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
CHEST DISCOMFORT
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
CHILLS
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
FEELING HOT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.9%
5/42 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
5/63 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
GLUCOSE URINE PRESENT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.7%
2/23 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
PULMONARY FUNCTION TEST DECREASED
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD IMMUNOGLOBULIN E INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD SODIUM DECREASED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD URINE PRESENT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
HEPATIC ENZYME INCREASED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
VIRAL INFECTION
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
RHINITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
21.7%
5/23 • Number of events 5 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.3%
3/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
3/38 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.8%
4/27 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
BACTERIAL DISEASE CARRIER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
4.9%
2/41 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
HYPOAESTHESIA FACIAL
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
RASH FOLLICULAR
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Congenital, familial and genetic disorders
CYSTIC FIBROSIS LUNG
|
4.9%
2/41 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
10.0%
2/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
16.7%
7/42 • Number of events 7 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.9%
3/38 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
14.8%
4/27 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
MENSTRUATION DELAYED
|
2.4%
1/41 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
PYURIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
15.9%
10/63 • Number of events 11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
11.3%
7/62 • Number of events 8 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
6/63 • Number of events 6 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Kidney infection
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Lung infection
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.5%
4/62 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
3/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Sputum abnormal
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Blood immunoglobulin G increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Eosinophil count increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Interleukin level increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.4%
2/27 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Protein total increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Transaminases increased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
Weight decreased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
2/42 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BACTERIA URINE IDENTIFIED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
CULTURE THROAT POSITIVE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
FUNGUS SPUTUM TEST POSITIVE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
PROTEIN URINE PRESENT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
URINE KETONE BODY PRESENT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Investigations
WHITE BLOOD CELLS URINE POSITIVE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
Chest pain
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
Malaise
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
APPLICATION SITE IRRITATION
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
FEELING OF BODY TEMPERATURE CHANGE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
8.7%
2/23 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
7.1%
3/42 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.5%
2/21 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MEDIAL TIBIAL STRESS SYNDROME
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
TORTICOLLIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
VERTEBRAL INJURY
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Ear and labyrinth disorders
EAR DISORDER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 3 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
18.2%
2/11 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
6.3%
4/63 • Number of events 4 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
BREAST TENDERNESS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
MENOMETRORRHAGIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
MENSTRUAL DISORDER
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.3%
1/23 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.2%
2/63 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/63 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Vascular disorders
Hot flush
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
1.6%
1/62 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
9.1%
1/11 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.0%
1/20 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Eye disorders
Vision Blurred
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/38 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
4.8%
1/21 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.4%
1/42 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
5.3%
2/38 • Number of events 2 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
3.7%
1/27 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
|
Infections and infestations
VIRAL RASH
|
0.00%
0/41 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/23 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/42 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/21 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/20 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
2.6%
1/38 • Number of events 1 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/11 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/27 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/63 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
0.00%
0/62 • Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER