Trial Outcomes & Findings for Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation (NCT NCT01946412)
NCT ID: NCT01946412
Last Updated: 2017-02-01
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 was considered treatment-emergent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
Results posted on
2017-02-01
Participant Flow
This was a Phase 3, multicenter, 2 arm study in participants who received at least 1 dose of study drug in parent study VX11-770-108 (study 108) (NCT01705145).
In study VX11-770-109 (study 109) (NCT01946412), participants were to be enrolled in either ivacaftor arm or observational arm. However, there were no participants enrolled in the observational arm. A total of 33 participants were enrolled in the ivacaftor arm.
Participant milestones
| Measure |
Ivacaftor
Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (\<) 6 years and weighing \<14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to \<6 years and weighing greater than or equal to (\>=) 14 kg and ivacaftor 150 mg q12h for participants \>=6 years.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Ivacaftor
Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (\<) 6 years and weighing \<14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to \<6 years and weighing greater than or equal to (\>=) 14 kg and ivacaftor 150 mg q12h for participants \>=6 years.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Non-Compliance
|
1
|
|
Overall Study
Continued with commercial Kalydeco
|
2
|
|
Overall Study
Difficulty in swallowing
|
1
|
Baseline Characteristics
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
Baseline characteristics by cohort
| Measure |
Ivacaftor
n=33 Participants
Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to \< 6 years and weighing \<14 kg, ivacaftor 75 mg q12h for participants aged 2 to \<6 years and weighing \>= 14 kg and ivacaftor 150 mg q12h for participants \>=6 years.
|
|---|---|
|
Age, Continuous
|
3.7 years
STANDARD_DEVIATION 1.04 • n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
|
Gender
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)Population: Safety set included all participants who received at least 1 dose of study drug in study 109 (NCT01946412). As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
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 was considered treatment-emergent.
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
9 participants
|
24 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline (study 108), Week 24, 48, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively.As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (\>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84
Baseline (n=7,22)
|
93.1 millimole per liter (mmol/L)
Standard Deviation 16.2
|
99.6 millimole per liter (mmol/L)
Standard Deviation 13.6
|
|
Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 24 (n=6,18)
|
-62.1 millimole per liter (mmol/L)
Standard Deviation 12.4
|
-48.5 millimole per liter (mmol/L)
Standard Deviation 18.4
|
|
Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 48 (n=6,15)
|
-29.3 millimole per liter (mmol/L)
Standard Deviation 37.8
|
-51.8 millimole per liter (mmol/L)
Standard Deviation 27.1
|
|
Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 72 (n=7,14)
|
-46.4 millimole per liter (mmol/L)
Standard Deviation 16.0
|
-52.9 millimole per liter (mmol/L)
Standard Deviation 26.7
|
|
Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 84 (n=6,14)
|
-46.5 millimole per liter (mmol/L)
Standard Deviation 31.0
|
-58.1 millimole per liter (mmol/L)
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Baseline (study 109), Week 24, 48, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of \>=15 microliter was required for determination of sweat chloride. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84
Baseline (n= 8,23)
|
47.8 mmol/L
Standard Deviation 23.3
|
52.9 mmol/L
Standard Deviation 23.1
|
|
Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 24 (n=7,18)
|
-4.3 mmol/L
Standard Deviation 31.6
|
3.4 mmol/L
Standard Deviation 15.9
|
|
Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 48 (n=7,17)
|
18.1 mmol/L
Standard Deviation 39.5
|
-4.5 mmol/L
Standard Deviation 22.6
|
|
Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 72 (n=8,15)
|
-1.5 mmol/L
Standard Deviation 24.3
|
-6.0 mmol/L
Standard Deviation 20.8
|
|
Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84
Absolute Change at Week 84 (n=7,16)
|
-2.4 mmol/L
Standard Deviation 44.2
|
-11.2 mmol/L
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145)
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n=9, 24)
|
12.5 kilogram (kg)
Standard Deviation 1.1
|
16.8 kilogram (kg)
Standard Deviation 1.8
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 12 (n= 9, 23)
|
1.3 kilogram (kg)
Standard Deviation 0.4
|
1.9 kilogram (kg)
Standard Deviation 0.7
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 24 (n=9, 23)
|
2.0 kilogram (kg)
Standard Deviation 0.6
|
2.5 kilogram (kg)
Standard Deviation 0.9
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 36 (n=9, 23)
|
2.4 kilogram (kg)
Standard Deviation 0.7
|
3.1 kilogram (kg)
Standard Deviation 1.0
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 48 (n=9, 22)
|
2.6 kilogram (kg)
Standard Deviation 0.9
|
3.4 kilogram (kg)
Standard Deviation 1.1
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 60 (n=9, 22)
|
3.2 kilogram (kg)
Standard Deviation 1.0
|
4.0 kilogram (kg)
Standard Deviation 1.3
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 72 (n=9, 20)
|
3.4 kilogram (kg)
Standard Deviation 0.9
|
4.8 kilogram (kg)
Standard Deviation 1.6
|
|
Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 84 (n=9, 19)
|
4.0 kilogram (kg)
Standard Deviation 1.2
|
5.7 kilogram (kg)
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n= 9, 24)
|
13.5 Kg
Standard Deviation 1.0
|
18.3 Kg
Standard Deviation 2.0
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 12 (n=9, 23)
|
0.3 Kg
Standard Deviation 0.4
|
0.4 Kg
Standard Deviation 0.5
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 24 (n=9, 23)
|
1.0 Kg
Standard Deviation 0.5
|
1.0 Kg
Standard Deviation 0.7
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 36 (n=9, 23)
|
1.4 Kg
Standard Deviation 0.6
|
1.6 Kg
Standard Deviation 0.8
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 48 (n=9, 22)
|
1.6 Kg
Standard Deviation 0.7
|
1.9 Kg
Standard Deviation 0.8
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 60 (n=9, 22)
|
2.2 Kg
Standard Deviation 0.8
|
2.5 Kg
Standard Deviation 1.1
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 72 (n=9, 20)
|
2.4 Kg
Standard Deviation 0.7
|
3.3 Kg
Standard Deviation 1.4
|
|
Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 84 (n=9, 19)
|
3.0 Kg
Standard Deviation 1.0
|
4.2 Kg
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n=9, 24)
|
89.1 Centimeters (cm)
Standard Deviation 4.3
|
102.3 Centimeters (cm)
Standard Deviation 6.4
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 12 (n=9, 23)
|
4.6 Centimeters (cm)
Standard Deviation 1.2
|
5.4 Centimeters (cm)
Standard Deviation 1.1
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 24 (n=9, 23)
|
6.0 Centimeters (cm)
Standard Deviation 1.7
|
7.7 Centimeters (cm)
Standard Deviation 3.3
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 36 (n=9, 23)
|
7.8 Centimeters (cm)
Standard Deviation 1.8
|
8.8 Centimeters (cm)
Standard Deviation 1.4
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 48 (n=9, 21)
|
9.7 Centimeters (cm)
Standard Deviation 2.0
|
10.4 Centimeters (cm)
Standard Deviation 1.7
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 60 (n=9, 22)
|
11.0 Centimeters (cm)
Standard Deviation 2.2
|
11.6 Centimeters (cm)
Standard Deviation 2.0
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 72 (n=9, 20)
|
12.5 Centimeters (cm)
Standard Deviation 2.6
|
13.4 Centimeters (cm)
Standard Deviation 2.0
|
|
Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change in Week 84 (n=9, 19)
|
13.6 Centimeters (cm)
Standard Deviation 2.3
|
15.0 Centimeters (cm)
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n=9, 24)
|
91.7 cm
Standard Deviation 4.3
|
105.8 cm
Standard Deviation 6.6
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 12 (n=9, 23)
|
2.0 cm
Standard Deviation 1.1
|
1.8 cm
Standard Deviation 0.9
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 24 (n=9, 23)
|
3.4 cm
Standard Deviation 1.2
|
4.1 cm
Standard Deviation 3.2
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 36 (n=9, 23)
|
5.2 cm
Standard Deviation 1.5
|
5.2 cm
Standard Deviation 1.1
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 48 (n=9, 21)
|
7.2 cm
Standard Deviation 1.3
|
6.8 cm
Standard Deviation 1.3
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 60 (n=9, 22)
|
8.4 cm
Standard Deviation 1.4
|
8.0 cm
Standard Deviation 1.5
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 72 (n=9, 20)
|
10.0 cm
Standard Deviation 2.1
|
9.8 cm
Standard Deviation 1.6
|
|
Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 84 (n=9, 19)
|
11.1 cm
Standard Deviation 1.7
|
11.4 cm
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
BMI = (Weight \[in kg\]) divided by (Stature \[in meters\]) \^2. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n=9, 24)
|
15.74 Kilogram per square meter (kg/m^2)
Standard Deviation 0.69
|
16.06 Kilogram per square meter (kg/m^2)
Standard Deviation 1.15
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 12 (n=9, 23)
|
0.03 Kilogram per square meter (kg/m^2)
Standard Deviation 0.40
|
0.09 Kilogram per square meter (kg/m^2)
Standard Deviation 0.60
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 24 (n=9, 23)
|
0.31 Kilogram per square meter (kg/m^2)
Standard Deviation 0.57
|
-0.12 Kilogram per square meter (kg/m^2)
Standard Deviation 0.90
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 36 (n=9, 23)
|
0.15 Kilogram per square meter (kg/m^2)
Standard Deviation 0.52
|
0.09 Kilogram per square meter (kg/m^2)
Standard Deviation 0.73
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 48 (n=9, 22)
|
-0.31 Kilogram per square meter (kg/m^2)
Standard Deviation 0.60
|
-0.13 Kilogram per square meter (kg/m^2)
Standard Deviation 0.77
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 60 (n=9, 22)
|
-0.12 Kilogram per square meter (kg/m^2)
Standard Deviation 0.70
|
-0.06 Kilogram per square meter (kg/m^2)
Standard Deviation 0.90
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 72 (n=9, 20)
|
-0.38 Kilogram per square meter (kg/m^2)
Standard Deviation 0.68
|
0.09 Kilogram per square meter (kg/m^2)
Standard Deviation 0.97
|
|
Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 84 (n=9, 19)
|
-0.16 Kilogram per square meter (kg/m^2)
Standard Deviation 0.96
|
0.28 Kilogram per square meter (kg/m^2)
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)Population: Safety set. Here "n" signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
BMI = (Weight \[in kg\]) divided by (Stature \[in meters\]) \^2. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).
Outcome measures
| Measure |
Ivacaftor 50 mg
n=9 Participants
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 Participants
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Baseline (n= 9, 24)
|
16.07 kg/m^2
Standard Deviation 0.55
|
16.33 kg/m^2
Standard Deviation 1.12
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 12 (n= 9, 23)
|
-0.30 kg/m^2
Standard Deviation 0.60
|
-0.16 kg/m^2
Standard Deviation 0.48
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 24 (n= 9, 23)
|
-0.02 kg/m^2
Standard Deviation 0.70
|
-0.36 kg/m^2
Standard Deviation 1.03
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 36 (n= 9, 23)
|
-0.18 kg/m^2
Standard Deviation 0.83
|
-0.16 kg/m^2
Standard Deviation 0.63
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 48 (n= 9, 22)
|
-0.64 kg/m^2
Standard Deviation 0.81
|
-0.35 kg/m^2
Standard Deviation 0.57
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 60 (n= 9, 22)
|
-0.45 kg/m^2
Standard Deviation 0.82
|
-0.29 kg/m^2
Standard Deviation 0.72
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 72 (n= 9, 20)
|
-0.71 kg/m^2
Standard Deviation 0.90
|
-0.21 kg/m^2
Standard Deviation 0.78
|
|
Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84
Absolute Change at Week 84 (n= 9, 19)
|
-0.49 kg/m^2
Standard Deviation 1.09
|
-0.01 kg/m^2
Standard Deviation 0.87
|
Adverse Events
Ivacaftor 50 mg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Ivacaftor 75 mg
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ivacaftor 50 mg
n=9 participants at risk
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 participants at risk
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
33.3%
3/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
12.5%
3/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Adenovirus test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Nervous system disorders
Seizure anoxic
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
Other adverse events
| Measure |
Ivacaftor 50 mg
n=9 participants at risk
Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
Ivacaftor 75 mg
n=24 participants at risk
Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to \<6 years and weighing \<14 kg or ivacaftor 75 mg q12h for participants aged 2 to \<6 years and \>=14 kg or ivacaftor 150 mg q12h for participants \>=6 years in this study (NCT01946412).
|
|---|---|---|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Otitis media
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
16.7%
4/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Sinusitis
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
12.5%
3/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
20.8%
5/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
16.7%
4/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
16.7%
4/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Pharyngitis streptococcal
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
12.5%
3/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Rhinitis
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Varicella
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Ear infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Herpangina
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Myringitis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Streptococcal infection
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
88.9%
8/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
66.7%
16/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
44.4%
4/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
12.5%
3/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
44.4%
4/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
6/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
29.2%
7/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
20.8%
5/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Gastrointestinal disorders
Tooth discolouration
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
General disorders
Pyrexia
|
77.8%
7/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
25.0%
6/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
General disorders
Fatigue
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
16.7%
4/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
12.5%
3/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Bacterial test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Haemophilus test positive
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
8.3%
2/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Respiratory rate increased
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Adenovirus test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Antibiotic resistant Staphylococcus test positive
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Lymph node palpable
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Pseudomonas test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Respiratory syncytial virus test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Investigations
Staphylococcus test positive
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Eye disorders
Conjunctivitis
|
22.2%
2/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Eye disorders
Amblyopia
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Eye disorders
Cataract cortical
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Psychiatric disorders
Encopresis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Psychiatric disorders
Onychophagia
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Renal and urinary disorders
Micturition urgency
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Hepatobiliary disorders
Cholelithiasis
|
11.1%
1/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
0.00%
0/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
4.2%
1/24 • Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)
As per the planned analysis for this study, participants were to be reported based on their dosing groups as per parent study VX11-770-108 (NCT01705145).
|
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