Trial Outcomes & Findings for Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation (NCT NCT01531673)
NCT ID: NCT01531673
Last Updated: 2018-04-13
Results Overview
An AE is defined as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the Informed Consent Form is signed. AE includes serious as well as non-serious AEs. Serious Adverse Event (SAE) is any AE that results in any of the following: death; life-threatening condition; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or other important medical event. Treatment-emergent adverse events are defined as adverse events that were reported or worsened on or after start of study drug through the Follow-up Visit (28 days after last dose of study drug) or premature discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
Start of study drug through the Follow-up Visit (Up to Day 56)
Results posted on
2018-04-13
Participant Flow
A total of 194 participants were randomized of which 190 participants were treated.
Participant milestones
| Measure |
Group 1-6d Combined: Placebo
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
All participants in group 1 who received VX-661 10 milligram (mg) tablet orally once daily (qd) for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet every 12 hours (q12h) for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
8
|
8
|
18
|
8
|
19
|
17
|
9
|
17
|
19
|
16
|
4
|
14
|
|
Overall Study
COMPLETED
|
33
|
7
|
8
|
17
|
7
|
18
|
17
|
9
|
17
|
18
|
16
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1-6d Combined: Placebo
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
All participants in group 1 who received VX-661 10 milligram (mg) tablet orally once daily (qd) for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet every 12 hours (q12h) for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
Baseline characteristics by cohort
| Measure |
Group 1-6d Combined: Placebo
n=33 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=8 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=18 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=8 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=19 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=9 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
n=19 Participants
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
n=16 Participants
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
n=4 Participants
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
n=14 Participants
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 7.05 • n=4 Participants
|
29.1 years
STANDARD_DEVIATION 7.12 • n=21 Participants
|
29.2 years
STANDARD_DEVIATION 6.39 • n=8 Participants
|
31 years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
28.2 years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
28.2 years
STANDARD_DEVIATION 6.46 • n=42 Participants
|
27.9 years
STANDARD_DEVIATION 5.58 • n=42 Participants
|
32.8 years
STANDARD_DEVIATION 11.92 • n=42 Participants
|
34.5 years
STANDARD_DEVIATION 7.59 • n=42 Participants
|
26.6 years
STANDARD_DEVIATION 7.01 • n=36 Participants
|
29.8 years
STANDARD_DEVIATION 7.97 • n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
83 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
107 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Start of study drug through the Follow-up Visit (Up to Day 56)Population: Analysis was done using safety set which included all participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the Informed Consent Form is signed. AE includes serious as well as non-serious AEs. Serious Adverse Event (SAE) is any AE that results in any of the following: death; life-threatening condition; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or other important medical event. Treatment-emergent adverse events are defined as adverse events that were reported or worsened on or after start of study drug through the Follow-up Visit (28 days after last dose of study drug) or premature discontinuation.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=33 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=8 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=18 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=8 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=19 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=9 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
n=19 Participants
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
n=16 Participants
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
n=4 Participants
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
n=14 Participants
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety as Determined by Adverse Events (AEs)
Participants with AEs
|
30 participants
|
8 participants
|
7 participants
|
15 participants
|
7 participants
|
18 participants
|
10 participants
|
8 participants
|
17 participants
|
16 participants
|
16 participants
|
2 participants
|
12 participants
|
|
Safety as Determined by Adverse Events (AEs)
Participants with SAEs
|
5 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 28Population: The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=8 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=6 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=18 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=8 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=18 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=17 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=24 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b
|
3.92 millimole per liter (mmol/L)
Interval -0.5 to 8.34
|
-4.76 millimole per liter (mmol/L)
Interval -9.75 to 0.22
|
-5.06 millimole per liter (mmol/L)
Interval -8.02 to -2.09
|
-20.43 millimole per liter (mmol/L)
Interval -24.75 to -16.12
|
-6 millimole per liter (mmol/L)
Interval -8.98 to 3.02
|
-6.04 millimole per liter (mmol/L)
Interval -9.12 to -2.96
|
-10.46 millimole per liter (mmol/L)
Interval -14.53 to -6.39
|
-2.63 millimole per liter (mmol/L)
Interval -5.67 to 0.41
|
-0.86 millimole per liter (mmol/L)
Interval -3.36 to 1.65
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 28Population: The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=18 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=16 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=14 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6
|
-6.07 mmol/L
Interval -10.84 to -1.31
|
-7.89 mmol/L
Interval -12.3 to -3.48
|
-1.19 mmol/L
Interval -5.5 to 3.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=4 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=13 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7
|
10.18 mmol/L
Interval -2.48 to 22.84
|
-7.02 mmol/L
Interval -14.15 to 0.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=8 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=18 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=8 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=18 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=17 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=24 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b
Day 7
|
1.73 mmol/L
Interval -3.82 to 7.29
|
-3.13 mmol/L
Interval -9.5 to 3.25
|
-5.37 mmol/L
Interval -9.24 to -1.49
|
-19.48 mmol/L
Interval -25.0 to -13.97
|
-5.02 mmol/L
Interval -8.85 to -1.19
|
-6.85 mmol/L
Interval -10.72 to -2.99
|
-13.89 mmol/L
Interval -19.09 to -8.69
|
-0.59 mmol/L
Interval -4.38 to 3.2
|
0.22 mmol/L
Interval -3.01 to 3.45
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b
Day 14
|
0.91 mmol/L
Interval -4.64 to 6.46
|
-7.88 mmol/L
Interval -14.25 to -1.5
|
-6.55 mmol/L
Interval -10.34 to -2.76
|
-28.23 mmol/L
Interval -33.75 to 22.72
|
-6.77 mmol/L
Interval -10.81 to -2.74
|
-7.37 mmol/L
Interval -11.44 to -3.3
|
-10.28 mmol/L
Interval -15.48 to -5.08
|
-2.4 mmol/L
Interval -6.38 to 1.58
|
-1.32 mmol/L
Interval -4.5 to 1.87
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b
Day 21
|
4.84 mmol/L
Interval -0.99 to 10.66
|
-4.61 mmol/L
Interval -10.98 to 1.76
|
-3.7 mmol/L
Interval -7.48 to 0.09
|
-18.78 mmol/L
Interval -24.3 to -13.27
|
-5.83 mmol/L
Interval -9.77 to -1.89
|
-4.26 mmol/L
Interval -8.44 to -0.08
|
-12.17 mmol/L
Interval -17.37 to -6.97
|
-3.9 mmol/L
Interval -7.88 to 0.08
|
-1.05 mmol/L
Interval -4.29 to 2.18
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b
Day 28
|
8.19 mmol/L
Interval 2.37 to 14.02
|
-3.44 mmol/L
Interval -9.82 to 2.93
|
-4.62 mmol/L
Interval -8.41 to -0.83
|
-15.23 mmol/L
Interval -20.75 to -9.72
|
-6.37 mmol/L
Interval -10.22 to -2.52
|
-5.68 mmol/L
Interval -9.76 to -1.61
|
-5.5 mmol/L
Interval -10.7 to 0.3
|
-3.62 mmol/L
Interval -7.6 to 0.36
|
-1.27 mmol/L
Interval -4.55 to 2.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=19 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=16 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=14 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6
Day 21
|
-6.34 mmol/L
Interval -12.0 to 0.68
|
-6.98 mmol/L
Interval -12.2 to -1.76
|
-2.47 mmol/L
Interval -7.67 to 2.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6
Day 7
|
-6.61 mmol/L
Interval -12.06 to -1.16
|
-11.04 mmol/L
Interval -16.37 to -5.7
|
-0.36 mmol/L
Interval -5.54 to 4.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6
Day 14
|
-7.9 mmol/L
Interval -13.25 to -2.55
|
-7.11 mmol/L
Interval -12.34 to -1.88
|
-2.1 mmol/L
Interval -7.19 to 2.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6
Day 28
|
-3.44 mmol/L
Interval -8.85 to 1.97
|
-6.43 mmol/L
Interval -11.55 to -1.31
|
0.19 mmol/L
Interval -5.01 to 5.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=4 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=14 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7
Day 28
|
15.73 mmol/L
Interval 1.85 to 29.61
|
-7.72 mmol/L
Interval -15.31 to -0.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7
Day 7
|
4.87 mmol/L
Interval -8.32 to 18.06
|
-7.28 mmol/L
Interval -14.76 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7
Day 14
|
10.75 mmol/L
Interval -2.44 to 23.94
|
-8.95 mmol/L
Interval -16.54 to -1.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7
Day 21
|
9.37 mmol/L
Interval -3.82 to 22.56
|
-4.14 mmol/L
Interval -11.86 to 3.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=8 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=18 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=8 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=19 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=17 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=24 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Post-Baseline Through Day 28
|
3.49 percent predicted of FEV1
Interval 0.21 to 6.77
|
1.63 percent predicted of FEV1
Interval -1.62 to 4.87
|
1.3 percent predicted of FEV1
Interval -0.87 to 3.47
|
1.6 percent predicted of FEV1
Interval -1.64 to 4.85
|
2.9 percent predicted of FEV1
Interval 0.76 to 5.03
|
3.75 percent predicted of FEV1
Interval 1.47 to 6.02
|
2.54 percent predicted of FEV1
Interval -0.53 to 5.61
|
3.61 percent predicted of FEV1
Interval 1.36 to 5.86
|
-0.14 percent predicted of FEV1
Interval -2.02 to 1.74
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 7
|
2.72 percent predicted of FEV1
Interval -1.17 to 6.62
|
0.8 percent predicted of FEV1
Interval -3.09 to 4.69
|
0.47 percent predicted of FEV1
Interval -2.13 to 3.06
|
3 percent predicted of FEV1
Interval -0.89 to 6.89
|
2.9 percent predicted of FEV1
Interval 0.37 to 5.42
|
2.66 percent predicted of FEV1
Interval -0.01 to 5.33
|
0.5 percent predicted of FEV1
Interval -3.17 to 4.18
|
2.51 percent predicted of FEV1
Interval -0.16 to 5.18
|
-0.41 percent predicted of FEV1
Interval -2.66 to 1.84
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 21
|
2.71 percent predicted of FEV1
Interval -1.34 to 6.76
|
1.8 percent predicted of FEV1
Interval -2.09 to 5.69
|
1.84 percent predicted of FEV1
Interval -0.75 to 4.44
|
0.25 percent predicted of FEV1
Interval -3.64 to 4.15
|
3.88 percent predicted of FEV1
Interval 1.27 to 6.5
|
3.37 percent predicted of FEV1
Interval 0.58 to 6.15
|
4.52 percent predicted of FEV1
Interval 0.85 to 8.19
|
4.08 percent predicted of FEV1
Interval 1.36 to 6.8
|
0.18 percent predicted of FEV1
Interval -2.07 to 2.43
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 28
|
3.26 percent predicted of FEV1
Interval -0.79 to 7.32
|
0.19 percent predicted of FEV1
Interval -3.7 to 4.08
|
1.99 percent predicted of FEV1
Interval -0.65 to 4.63
|
1.55 percent predicted of FEV1
Interval -2.34 to 5.45
|
3.02 percent predicted of FEV1
Interval 0.4 to 5.63
|
4.44 percent predicted of FEV1
Interval 1.66 to 7.23
|
2.34 percent predicted of FEV1
Interval -1.33 to 6.01
|
4.13 percent predicted of FEV1
Interval 1.41 to 6.86
|
-0.36 percent predicted of FEV1
Interval -2.63 to 1.92
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 14
|
5.25 percent predicted of FEV1
Interval 1.35 to 9.15
|
3.72 percent predicted of FEV1
Interval -0.17 to 7.61
|
0.91 percent predicted of FEV1
Interval -1.69 to 3.5
|
1.61 percent predicted of FEV1
Interval -2.28 to 5.5
|
1.79 percent predicted of FEV1
Interval -0.78 to 4.36
|
4.52 percent predicted of FEV1
Interval 1.73 to 7.3
|
2.79 percent predicted of FEV1
Interval -1.0 to 6.59
|
3.72 percent predicted of FEV1
Interval 1.0 to 6.44
|
0.03 percent predicted of FEV1
Interval -2.21 to 2.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=19 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=16 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=14 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 21
|
0.36 percent predicted of FEV1
Interval -2.38 to 3.11
|
3.21 percent predicted of FEV1
Interval 0.33 to 6.08
|
1.73 percent predicted of FEV1
Interval -1.39 to 4.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 28
|
0.81 percent predicted of FEV1
Interval -1.97 to 3.6
|
1.56 percent predicted of FEV1
Interval -1.32 to 4.44
|
1.67 percent predicted of FEV1
Interval -1.45 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Post-Baseline Through Day 28
|
0.94 percent predicted of FEV1
Interval -1.42 to 3.3
|
2.31 percent predicted of FEV1
Interval -0.19 to 4.8
|
1.47 percent predicted of FEV1
Interval -1.2 to 4.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 7
|
1.37 percent predicted of FEV1
Interval -1.33 to 4.08
|
1.95 percent predicted of FEV1
Interval -0.93 to 4.82
|
1.09 percent predicted of FEV1
Interval -1.97 to 4.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 14
|
1.2 percent predicted of FEV1
Interval -1.55 to 3.95
|
2.52 percent predicted of FEV1
Interval -0.36 to 5.4
|
1.37 percent predicted of FEV1
Interval -1.69 to 4.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=4 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=14 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Post-Baseline Through Day 28
|
1.4 percent predicted of FEV1
Interval -5.04 to 7.83
|
4.6 percent predicted of FEV1
Interval 1.17 to 8.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 7
|
3 percent predicted of FEV1
Interval -3.55 to 9.55
|
4.14 percent predicted of FEV1
Interval 0.65 to 7.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 14
|
0.98 percent predicted of FEV1
Interval -5.56 to 7.53
|
5.22 percent predicted of FEV1
Interval 1.73 to 8.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 21
|
2.72 percent predicted of FEV1
Interval -3.83 to 9.27
|
3.88 percent predicted of FEV1
Interval 0.39 to 7.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 28
|
-1.12 percent predicted of FEV1
Interval -7.66 to 5.43
|
5.16 percent predicted of FEV1
Interval 1.67 to 8.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=8 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=18 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=8 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=19 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=17 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=24 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 14
|
0.2 Liters
Interval 0.05 to 0.34
|
0.14 Liters
Interval -0.01 to 0.28
|
0.03 Liters
Interval -0.07 to 0.12
|
0.04 Liters
Interval -0.11 to 0.19
|
0.05 Liters
Interval -0.04 to 0.15
|
0.17 Liters
Interval 0.06 to 0.27
|
0.11 Liters
Interval -0.03 to 0.25
|
0.12 Liters
Interval 0.02 to 0.23
|
0.02 Liters
Interval -0.07 to 0.1
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 28
|
0.13 Liters
Interval -0.02 to 0.28
|
0.03 Liters
Interval -0.11 to 0.18
|
0.08 Liters
Interval -0.02 to 0.18
|
0.04 Liters
Interval -0.11 to 0.18
|
0.1 Liters
Interval 0.01 to 0.2
|
0.16 Liters
Interval 0.06 to 0.27
|
0.09 Liters
Interval -0.05 to 0.23
|
0.15 Liters
Interval 0.05 to 0.26
|
0.01 Liters
Interval -0.08 to 0.09
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
PB Through Day 28
|
0.14 Liters
Interval 0.02 to 0.26
|
0.07 Liters
Interval -0.05 to 0.19
|
0.05 Liters
Interval -0.03 to 0.13
|
0.04 Liters
Interval -0.08 to 0.16
|
0.1 Liters
Interval 0.02 to 0.18
|
0.14 Liters
Interval 0.06 to 0.23
|
0.1 Liters
Interval -0.01 to 0.21
|
0.12 Liters
Interval 0.04 to 0.21
|
0.01 Liters
Interval -0.06 to 0.08
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 7
|
0.11 Liters
Interval -0.04 to 0.25
|
0.02 Liters
Interval -0.13 to 0.16
|
0.02 Liters
Interval -0.08 to 0.12
|
0.09 Liters
Interval -0.06 to 0.24
|
0.1 Liters
Interval 0.0 to 0.19
|
0.11 Liters
Interval 0.01 to 0.21
|
0.02 Liters
Interval -0.12 to 0.16
|
0.08 Liters
Interval -0.02 to 0.18
|
-0.01 Liters
Interval -0.09 to 0.08
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 21
|
0.12 Liters
Interval -0.03 to 0.27
|
0.08 Liters
Interval -0.06 to 0.23
|
0.07 Liters
Interval -0.03 to 0.17
|
0 Liters
Interval -0.15 to 0.15
|
0.14 Liters
Interval 0.04 to 0.23
|
0.13 Liters
Interval 0.02 to 0.23
|
0.18 Liters
Interval 0.04 to 0.31
|
0.14 Liters
Interval 0.04 to 0.24
|
0.02 Liters
Interval -0.06 to 0.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=19 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=16 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=14 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 21
|
-0.01 Liters
Interval -0.11 to 0.1
|
0.13 Liters
Interval 0.02 to 0.24
|
0.08 Liters
Interval -0.04 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Post-Baseline Through Day 28
|
0.02 Liters
Interval -0.07 to 0.11
|
0.09 Liters
Interval -0.01 to 0.18
|
0.07 Liters
Interval -0.04 to 0.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 7
|
0.04 Liters
Interval -0.07 to 0.14
|
0.06 Liters
Interval -0.05 to 0.17
|
0.05 Liters
Interval -0.06 to 0.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 14
|
0.03 Liters
Interval -0.07 to 0.14
|
0.1 Liters
Interval -0.01 to 0.21
|
0.06 Liters
Interval -0.05 to 0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 28
|
0.02 Liters
Interval -0.08 to 0.13
|
0.06 Liters
Interval -0.05 to 0.17
|
0.08 Liters
Interval -0.04 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 21, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=4 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=14 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 14
|
0.08 Liters
Interval -0.17 to 0.33
|
0.18 Liters
Interval 0.05 to 0.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 21
|
0.14 Liters
Interval -0.11 to 0.4
|
0.13 Liters
Interval -0.01 to 0.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 28
|
-0.01 Liters
Interval -0.26 to 0.25
|
0.19 Liters
Interval 0.05 to 0.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Post-Baseline Through Day 28
|
0.09 Liters
Interval -0.16 to 0.34
|
0.16 Liters
Interval 0.03 to 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 7
|
0.14 Liters
Interval -0.11 to 0.39
|
0.15 Liters
Interval 0.01 to 0.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=8 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=18 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=8 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=19 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=17 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=17 Participants
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=24 Participants
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
PB Through Day 28
|
4.02 units on a scale
Interval -4.38 to 12.43
|
5.54 units on a scale
Interval -2.72 to 13.79
|
3.8 units on a scale
Interval -1.74 to 9.35
|
0.61 units on a scale
Interval -7.64 to 8.86
|
3.52 units on a scale
Interval -2.02 to 9.06
|
5.15 units on a scale
Interval -0.88 to 11.19
|
2.58 units on a scale
Interval -5.21 to 10.37
|
7.62 units on a scale
Interval 1.78 to 13.45
|
1.69 units on a scale
Interval -3.1 to 6.48
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 28
|
1.38 units on a scale
Interval -8.7 to 11.45
|
6.23 units on a scale
Interval -3.34 to 15.8
|
3.31 units on a scale
Interval -3.21 to 9.84
|
0.95 units on a scale
Interval -8.61 to 10.52
|
4.22 units on a scale
Interval -2.29 to 10.74
|
5.9 units on a scale
Interval -1.1 to 12.89
|
1.03 units on a scale
Interval -8.0 to 10.06
|
8.1 units on a scale
Interval 1.34 to 14.87
|
2.85 units on a scale
Interval -2.76 to 8.46
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b
Day 14
|
6.67 units on a scale
Interval -2.9 to 16.25
|
4.84 units on a scale
Interval -4.73 to 14.41
|
4.29 units on a scale
Interval -2.09 to 10.67
|
0.27 units on a scale
Interval -9.3 to 9.83
|
2.81 units on a scale
Interval -3.56 to 9.19
|
4.41 units on a scale
Interval -2.58 to 11.4
|
4.13 units on a scale
Interval -4.9 to 13.16
|
7.13 units on a scale
Interval 0.37 to 13.89
|
0.53 units on a scale
Interval -4.99 to 6.05
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=19 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=16 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=14 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Post-Baseline Through Day 28
|
0.87 units on a scale
Interval -4.44 to 6.19
|
1.91 units on a scale
Interval -3.5 to 7.33
|
1.65 units on a scale
Interval -4.18 to 7.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 14
|
2.02 units on a scale
Interval -3.97 to 8.02
|
0.87 units on a scale
Interval -5.25 to 6.99
|
2.78 units on a scale
Interval -3.76 to 9.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6
Day 28
|
-0.27 units on a scale
Interval -6.27 to 5.72
|
2.96 units on a scale
Interval -3.16 to 9.08
|
0.53 units on a scale
Interval -6.18 to 7.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Population: The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=4 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=14 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Post-Baseline Through Day 28
|
-3.02 units on a scale
Interval -13.52 to 7.47
|
3.79 units on a scale
Interval -1.78 to 9.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 14
|
1.83 units on a scale
Interval -10.64 to 14.3
|
5.24 units on a scale
Interval -1.56 to 12.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7
Day 28
|
-7.87 units on a scale
Interval -20.34 to 4.6
|
2.33 units on a scale
Interval -4.24 to 8.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: The analysis was done using Pharmacokinetics (PK) Set.
Participants who received VX-661 monotherapy (Group 1, 2a, 3a and 5a) were analyzed for this outcome measure. PK analysis (AUC0-24h) was not planned for placebo reporting arms.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=7 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=8 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=9 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661 After Administration of VX-661 Monotherapy
|
6260 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2650
|
23000 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 6550
|
88100 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 51100
|
98900 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 20200
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: The analysis was done using PK Set.
Participants who received VX-661 in combination with Ivacaftor (Group 2b, 3b, 4, 5b, 6a, 6d and 7) were analyzed for this outcome measure. PK analysis was not planned for placebo reporting arms.
Outcome measures
| Measure |
Group 1-6d Combined: Placebo
n=17 Participants
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=13 Participants
All participants in group 1 who received VX-661 10 mg tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=15 Participants
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=16 Participants
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=17 Participants
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=15 Participants
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=14 Participants
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-24h of VX-661 and AUC0-12h of Ivacaftor After Administration of VX-661 in Combination With Ivacaftor
AUC0-24h of VX-661
|
8950 ng*h/mL
Standard Deviation 2370
|
26300 ng*h/mL
Standard Deviation 5870
|
82700 ng*h/mL
Standard Deviation 23300
|
138000 ng*h/mL
Standard Deviation 49700
|
77600 ng*h/mL
Standard Deviation 17800
|
73300 ng*h/mL
Standard Deviation 22900
|
90600 ng*h/mL
Standard Deviation 30800
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-24h of VX-661 and AUC0-12h of Ivacaftor After Administration of VX-661 in Combination With Ivacaftor
AUC0-12h of Ivacaftor
|
10100 ng*h/mL
Standard Deviation 4380
|
11700 ng*h/mL
Standard Deviation 4870
|
10900 ng*h/mL
Standard Deviation 3890
|
16000 ng*h/mL
Standard Deviation 10400
|
3690 ng*h/mL
Standard Deviation 1460
|
11700 ng*h/mL
Standard Deviation 5450
|
12400 ng*h/mL
Standard Deviation 6170
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1-6d Combined: Placebo
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Group 1: VX-661 10 mg qd
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2a: VX-661 30 mg qd
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 3a: VX-661 100 mg qd
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 5a: VX-661 150 mg qd
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 7: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 7: VX-661 100 mg qd
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1-6d Combined: Placebo
n=33 participants at risk
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 participants at risk
All participants in group 1 who received VX-661 10 milligram (mg) tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=8 participants at risk
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=18 participants at risk
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=8 participants at risk
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=19 participants at risk
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=17 participants at risk
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=9 participants at risk
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=17 participants at risk
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
n=19 participants at risk
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
n=16 participants at risk
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
n=4 participants at risk
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
n=14 participants at risk
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Pyrexia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
15.2%
5/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
2/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
Other adverse events
| Measure |
Group 1-6d Combined: Placebo
n=33 participants at risk
All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days.
|
Group 1: VX-661 10 mg qd
n=8 participants at risk
All participants in group 1 who received VX-661 10 milligram (mg) tablet orally qd for up to 28 days.
|
Group 2a: VX-661 30 mg qd
n=8 participants at risk
All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h
n=18 participants at risk
All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 3a: VX-661 100 mg qd
n=8 participants at risk
All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days.
|
Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h
n=19 participants at risk
All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h
n=17 participants at risk
All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 5a: VX-661 150 mg qd
n=9 participants at risk
All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
|
Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h
n=17 participants at risk
All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h
n=19 participants at risk
All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days.
|
Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h
n=16 participants at risk
All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days.
|
Group 7: Placebo
n=4 participants at risk
All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
Group 7: VX-661 100 mg qd
n=14 participants at risk
All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Vascular disorders
Hot flush
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Immune system disorders
Seasonal allergy
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Fatigue
|
9.1%
3/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
50.0%
4/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
15.8%
3/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Pyrexia
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
14.3%
2/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Application site rash
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Thirst
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Application site erythema
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Catheter site haematoma
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Chest pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Disease progression
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Feeling abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Feeling hot
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Infusion site pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Infusion site swelling
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Malaise
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Medical device complication
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Vessel puncture site haematoma
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
General disorders
Vessel puncture site reaction
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Reproductive system and breast disorders
Breast tenderness
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Pulmonary function test decreased
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Weight decreased
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood glucose decreased
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Hepatic enzyme increased
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Blood potassium increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Gastrointestinal examination abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Platelet count decreased
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Transaminases increased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Urinary casts present
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Urine colour abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
Vitamin D decreased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Investigations
White blood cells urine positive
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
6/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
37.5%
3/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
37.5%
3/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
15.8%
3/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
22.2%
2/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
17.6%
3/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.1%
4/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
18.8%
3/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
28.6%
4/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
22.2%
2/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
18.8%
3/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
3/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
2/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
14.3%
2/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract irritation
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Headache
|
24.2%
8/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.1%
4/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.1%
4/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
4/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.4%
3/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Sinus headache
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
37.5%
3/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Lethargy
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Migraine
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Eye disorders
Dry eye
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Eye disorders
Vision blurred
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
44.4%
4/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
31.2%
5/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
14.3%
2/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
2/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
22.2%
2/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
15.8%
3/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
2/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Renal and urinary disorders
Leukocyturia
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
3/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
2/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Vitamin E deficiency
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
24.2%
8/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
22.2%
4/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.1%
4/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
17.6%
3/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.8%
2/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
18.8%
3/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.4%
3/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
3/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
2/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
21.4%
3/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
10.5%
2/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
17.6%
3/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
18.8%
3/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
1/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Sinusitis
|
9.1%
3/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
25.0%
2/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.6%
1/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
7.1%
1/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Oral candidiasis
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Acute sinusitis
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
12.5%
1/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Bronchitis
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Gastroenteritis viral
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Otitis media
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Rhinitis
|
6.1%
2/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
6.2%
1/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Lower respiratory tract infection viral
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.3%
1/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
5.9%
1/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.0%
1/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/33 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/18 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/8 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
11.1%
1/9 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/17 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/19 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/16 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/4 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
0.00%
0/14 • Start of study drug through the Follow-up Visit (Up to Day 56)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: PI is free to publish results of the study after (1)first multi-center publication, (2)if 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