Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion (NCT NCT02070744)
NCT ID: NCT02070744
Last Updated: 2025-09-24
Results Overview
AE: 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. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of PC Phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline (PC Phase) up to 112 days
Results posted on
2025-09-24
Participant Flow
The study consisted of 2 phases: a randomized, double-blind, placebo-controlled (PC) phase in which participants received either VX-661 in combination with Ivacaftor (IVA), or matched placebo and an open-label extension (OLE) phase in which participants received VX-661 in combination with IVA.
Participant milestones
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
Participants received VX-661 50 milligram (mg) tablet plus IVA 150 mg tablet every 12 hours (q12h) for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
|
|---|---|---|---|---|---|
|
PC Phase (12 Weeks)
STARTED
|
6
|
5
|
15
|
14
|
0
|
|
PC Phase (12 Weeks)
Treated
|
6
|
5
|
15
|
13
|
0
|
|
PC Phase (12 Weeks)
COMPLETED
|
6
|
5
|
15
|
13
|
0
|
|
PC Phase (12 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
|
OLE Phase (48 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
27
|
|
OLE Phase (48 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
24
|
|
OLE Phase (48 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
Participants received VX-661 50 milligram (mg) tablet plus IVA 150 mg tablet every 12 hours (q12h) for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
|
|---|---|---|---|---|---|
|
PC Phase (12 Weeks)
Randomized, but not treated
|
0
|
0
|
0
|
1
|
0
|
|
OLE Phase (48 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
|
OLE Phase (48 Weeks)
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
Baseline characteristics by cohort
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
27.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
28.8 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (PC Phase) up to 112 daysPopulation: Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase.
AE: 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. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
6 Participants
|
5 Participants
|
15 Participants
|
13 Participants
|
|
PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline (OLE Phase) up to 364 daysPopulation: Safety Set was defined as all participants who received at least 1 dose of study drug in OLE Phase.
AE: 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. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs
Participants with AEs
|
25 Participants
|
—
|
—
|
—
|
|
OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs
Participants with SAEs
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Through Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12
|
0.9 Percent predicted of FEV1
Interval -3.1 to 5.0
|
-0.1 Percent predicted of FEV1
Interval -4.4 to 4.3
|
3.0 Percent predicted of FEV1
Interval 0.4 to 5.5
|
1.9 Percent predicted of FEV1
Interval -0.9 to 4.6
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Through Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in OLE phase.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Absolute Change From Baseline in Percent Predicted FEV1 Through Week 40
|
2.7 Percent predicted of FEV1
Interval 0.4 to 4.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Through Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 12
|
2.6 Percent change
Interval -6.0 to 11.1
|
1.0 Percent change
Interval -8.2 to 10.3
|
6.0 Percent change
Interval 0.6 to 11.3
|
4.2 Percent change
Interval -1.5 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Through Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 40
|
6.1 Percent change
Interval 1.7 to 10.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Through Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=5 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=13 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Absolute Change From Baseline in Sweat Chloride Through Week 12
|
-10.6 Millimole per liter (mmol/L)
Interval -16.6 to -4.6
|
2.9 Millimole per liter (mmol/L)
Interval -3.0 to 8.9
|
-4.7 Millimole per liter (mmol/L)
Interval -8.4 to -0.9
|
0.8 Millimole per liter (mmol/L)
Interval -3.1 to 4.7
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Through Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=25 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Absolute Change From Baseline in Sweat Chloride Through Week 40
|
-6.6 mmol/L
Interval -9.7 to -3.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.
Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Absolute Change From Baseline in Body Weight at Week 12
|
1.0 kilogram (kg)
Interval -0.4 to 2.3
|
1.6 kilogram (kg)
Interval 0.1 to 3.0
|
0.5 kilogram (kg)
Interval -0.3 to 1.4
|
0.3 kilogram (kg)
Interval -0.6 to 1.3
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.
Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Absolute Change From Baseline in Body Weight at Week 40
|
1.0 kg
Interval -0.2 to 2.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.
BMI was calculated using following formula: BMI = Weight in kg/height in square meter (m\^2). Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Absolute Change From Baseline Body Mass Index (BMI) at Week 12
|
0.38 Kilogram per square meter (kg/m^2)
Interval -0.08 to 0.84
|
0.54 Kilogram per square meter (kg/m^2)
Interval 0.03 to 1.04
|
0.18 Kilogram per square meter (kg/m^2)
Interval -0.11 to 0.47
|
0.11 Kilogram per square meter (kg/m^2)
Interval -0.21 to 0.42
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.
BMI was calculated using following formula: BMI = Weight in kg/height in m\^2. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Absolute Change From Baseline BMI at Week 40
|
0.33 kg/m^2
Interval -0.09 to 0.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (PC Phase), Through Week 12Population: FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.
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. Baseline was defined as Day 1 of PC Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=5 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 Participants
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 Participants
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12
|
5.6 units on a scale
Interval -3.9 to 15.1
|
-4.6 units on a scale
Interval -14.9 to 5.7
|
1.0 units on a scale
Interval -5.1 to 7.0
|
0.4 units on a scale
Interval -6.2 to 7.1
|
SECONDARY outcome
Timeframe: Baseline (OLE Phase), Through Week 40Population: Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.
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. Baseline was defined as Day 1 of the OLE Phase.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=27 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
OLE Phase: Absolute Change From Baseline in CFQ-R Respiratory Domain Score Through Week 40
|
-0.6 units on a scale
Interval -5.8 to 4.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85Population: Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=15 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Maximum Plasma Concentration (Cmax) of VX-661 and IVA
VX-661
|
4890 Nanogram per milliliter (ng/mL)
Standard Deviation 3150
|
6460 Nanogram per milliliter (ng/mL)
Standard Deviation 1240
|
—
|
—
|
|
PC Phase: Maximum Plasma Concentration (Cmax) of VX-661 and IVA
IVA
|
1490 Nanogram per milliliter (ng/mL)
Standard Deviation 1150
|
1210 Nanogram per milliliter (ng/mL)
Standard Deviation 585
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85Population: Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Pharmacokinetic (PK) sampling was performed up to 12 hours post-dose on Day 85. For Arm VX-661 50 mg q12h + IVA 150 mg q12h (VX-661 q12h regimen), area under the concentration versus time curve from time 0 to 12 hours (AUC0-12h) was multiplied by 2 to obtain AUC0-24h.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=5 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=15 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661
|
84900 Hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 55900
|
75500 Hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 20300
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85Population: Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=5 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=15 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12h) of IVA
|
14700 hr*ng/mL
Standard Deviation 11600
|
10100 hr*ng/mL
Standard Deviation 4890
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85Population: Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.
Outcome measures
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 Participants
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX-661 Placebo q12h + IVA Placebo q12h
n=15 Participants
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
|---|---|---|---|---|
|
PC Phase: Time to Reach Cmax (Tmax) of VX-661 and IVA
VX-661
|
2.48 hour
Interval 1.75 to 4.08
|
3.23 hour
Interval 1.92 to 6.03
|
—
|
—
|
|
PC Phase: Time to Reach Cmax (Tmax) of VX-661 and IVA
IVA
|
3.59 hour
Interval 1.98 to 6.0
|
4.00 hour
Interval 2.98 to 6.03
|
—
|
—
|
Adverse Events
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PC Phase: VX 661 Placebo q12h + IVA Placebo q12h
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 participants at risk
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX 661 Placebo q12h + IVA Placebo q12h
n=5 participants at risk
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 participants at risk
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 participants at risk
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=27 participants at risk
Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
|
|---|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
40.0%
2/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
26.7%
4/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
30.8%
4/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
18.5%
5/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Chronic sinusitis
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
3.7%
1/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
3.7%
1/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
3.7%
1/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
Other adverse events
| Measure |
PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h
n=6 participants at risk
Participants received VX-661 50 mg tablet plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX 661 Placebo q12h + IVA Placebo q12h
n=5 participants at risk
Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks.
|
PC Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=15 participants at risk
Participants received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 12 weeks.
|
PC Phase: VX -661 Placebo qd + IVA Placebo q12h
n=13 participants at risk
Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks.
|
OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h
n=27 participants at risk
Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
|
|---|---|---|---|---|---|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
40.0%
2/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
26.7%
4/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
38.5%
5/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
37.0%
10/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
40.0%
2/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
3/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
23.1%
3/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
23.1%
3/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
40.0%
2/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
15.4%
2/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
14.8%
4/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
18.5%
5/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Pulmonary function test decreased
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Breath sounds abnormal
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Urine output decreased
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
15.4%
2/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
15.4%
2/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Vitamin A decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
Vitamin K decreased
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
60.0%
3/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
33.3%
5/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
30.8%
4/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
48.1%
13/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
3/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
15.4%
2/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
11.1%
3/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
13.3%
2/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
14.8%
4/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Hyposmia
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Vaccination site discomfort
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.4%
2/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Metabolism and nutrition disorders
Vitamin E deficiency
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Reproductive system and breast disorders
Testicular pain
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
20.0%
1/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
6.7%
1/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/6 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/5 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/15 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
7.7%
1/13 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
0.00%
0/27 • Baseline (Day 1 of PC Phase) up to 112 days (Placebo control phase); Baseline (Day 1 of OLE Phase) up to 364 days (OLE phase)
Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase and OLE Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER