Trial Outcomes & Findings for A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy (NCT NCT03447262)
NCT ID: NCT03447262
Last Updated: 2022-01-25
Results Overview
TERMINATED
PHASE3
484 participants
From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
2022-01-25
Participant Flow
A total of 484 participants were enrolled from the parent studies VX17-659-102 (Study 659-102; NCT03447249) and VX17-659-103 (Study 659-103; NCT03460990). Out of which, 3 participants were enrolled but never dosed in the current study VX17-659-105 (Study 659-105). Therefore, the below results are presented for 481 participants.
This study was conducted in cystic fibrosis (CF) participants aged 12 years or older who participated in parent studies 659-102 or 659-103. Eligible participants from the parent studies were enrolled in the current study 659-105.
Participant milestones
| Measure |
VX-659/TEZ/IVA Triple Combination (TC)
Participants from the parent studies 659-102 or 659-103 were administered VX-659 240 milligrams (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
|
Overall Study
STARTED
|
481
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
479
|
Reasons for withdrawal
| Measure |
VX-659/TEZ/IVA Triple Combination (TC)
Participants from the parent studies 659-102 or 659-103 were administered VX-659 240 milligrams (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
2
|
|
Overall Study
Commercial Drug is Available for Participant
|
9
|
|
Overall Study
Death
|
2
|
|
Overall Study
Study Termination by Sponsor
|
455
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
Baseline characteristics by cohort
| Measure |
VX-659/TEZ/IVA TC
n=481 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Age, Continuous
|
26.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
262 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
462 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
474 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)Population: Open label safety set (OL-SS) included all participants who received at least 1 dose of study drug in the current study 659-105.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=481 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With AEs
|
470 participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With SAEs
|
99 participants
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: Open label full analysis set (OL-FAS) included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=371 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
14.2 percentage points
Standard Deviation 7.8
|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
10.3 percentage points
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Absolute Change in ppFEV1 for Participants From the Parent Study 659-103
TEZ/IVA - VX-659/TEZ/IVA
|
15.1 percentage points
Standard Deviation 11.9
|
|
Absolute Change in ppFEV1 for Participants From the Parent Study 659-103
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
11.5 percentage points
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: From Baseline at Week 24 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
Sweat samples were collected using an approved collection device. The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=371 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Absolute Change in Sweat Chloride (SwCl) for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
-48.9 millimole per liter (mmol/L)
Standard Deviation 20.4
|
|
Absolute Change in Sweat Chloride (SwCl) for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
-49.7 millimole per liter (mmol/L)
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: From Baseline at Week 24 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
Sweat samples were collected using an approved collection device. The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Absolute Change in SwCl for Participants From the Parent Study 659-103
TEZ/IVA - VX-659/TEZ/IVA
|
-45.7 mmol/L
Standard Deviation 16.8
|
|
Absolute Change in SwCl for Participants From the Parent Study 659-103
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
-53.5 mmol/L
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96 (Study 659-105)Population: The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-102 and/or received at least one dose of study drug during the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
PEx was defined as treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for at least 4 sinopulmonary signs/symptoms. The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in the parent study 659-102 or/and VX-659/TEZ/IVA in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline except for Placebo - VX-659/TEZ/IVA category, for which the baseline was defined as study 659-105 baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=375 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Number of Pulmonary Exacerbations (PEx) for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
60 PEx events
|
|
Number of Pulmonary Exacerbations (PEx) for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
84 PEx events
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96 (Study 659-105)Population: The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-103 and/or received at least one dose of study drug during the current study 659-105.
PEx was defined as treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for at least 4 sinopulmonary signs/symptoms. The analysis was planned to be reported for overall participants from the parent study 659-103, that is combined for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in the parent study 659-103 or/and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline except for TEZ/IVA - VX-659/TEZ/IVA category, for which the baseline was defined as study 659-105 baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Number of PEx for Participants From the Parent Study 659-103
|
39 PEx events
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96 (Study 659-105)Population: The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-102 and/or received at least one dose of study drug during the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
PEx was defined as treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for at least 4 sinopulmonary signs/symptoms. The time-to-first-PEx data were planned to be estimated using the Kaplan-Meier (KM) method. However, because way less than 50% of participants had events, median time-to-first event data were not estimable. Instead, the number of participants with at least one PEx event was assessed and reported separately for those in Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and the VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in the parent study 659-102 or/and VX-659/TEZ/IVA in the current study 659-105). Baseline was defined as the parent study baseline except for Placebo - VX-659/TEZ/IVA category, for which the baseline was defined as study 659-105 baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=375 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
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|---|---|
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Number of Participants With at Least One PEx for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
43 participants
|
|
Number of Participants With at Least One PEx for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
52 participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96 (Study 659-105)Population: The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-103 and/or received at least one dose of study drug during the current study 659-105.
PEx was defined as treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for at least 4 sinopulmonary signs/symptoms. The time-to-first-PEx data were planned to be estimated using the KM method. However, because way less than 50% of participants had events, median time-to-first-event data were not estimable. Instead, the number of participants with at least one PEx event was assessed and reported for all participants from the parent study 659-103, that is combined for those in the TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and the VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in the parent study 659-103 or/and in the current study 659-105). Baseline was defined as the parent study baseline except for TEZ/IVA - VX-659/TEZ/IVA category, for which the baseline was defined as study 659-105 baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Number of Participants With at Least One PEx for Participants From the Parent Study 659-103
|
28 participants
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kilograms (kg) divided by squared height in meters (m\^2). The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=371 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in Body Mass Index (BMI) for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
1.55 kilogram per meter square (kg/m^2)
Standard Deviation 1.35
|
|
Absolute Change in Body Mass Index (BMI) for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
1.43 kilogram per meter square (kg/m^2)
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kg divided by squared height in meters (m\^2). The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in BMI for Participants From the Parent Study 659-103
TEZ/IVA - VX-659/TEZ/IVA
|
1.16 kg/m^2
Standard Deviation 1.68
|
|
Absolute Change in BMI for Participants From the Parent Study 659-103
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
0.90 kg/m^2
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: From Baseline at Week 60 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-102 who were \<=20 years old at parent study baseline and received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kg divided by squared height in meters (m\^2). The z-score is a statistical measure to describe whether a value was above or below the standard. A z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard. The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=114 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in BMI Z-score for Participants From the Parent Study 659-102 (Participants <=20 Years Old at Parent Study Baseline)
Placebo - VX-659/TEZ/IVA
|
0.22 z-score
Standard Deviation 0.59
|
|
Absolute Change in BMI Z-score for Participants From the Parent Study 659-102 (Participants <=20 Years Old at Parent Study Baseline)
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
0.10 z-score
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: From Baseline at Week 60 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who were \<=20 years old at parent study baseline and received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kg divided by squared height in meters (m\^2). The z-score is a statistical measure to describe whether a value was above or below the standard. A z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard. The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=30 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in BMI Z-score for Participants From The Parent Study 659-103 (Participants <=20 Years Old at Parent Study Baseline)
TEZ/IVA - VX-659/TEZ/IVA
|
NA z-score
Standard Deviation NA
As pre-specified in analysis plan, due to less than 20 number of participants in the TEZ/IVA - VX-659/TEZ/IVA category, the summary statistics were no longer applicable. Therefore, no BMI z-score efficacy data is available for this category.
|
|
Absolute Change in BMI Z-score for Participants From The Parent Study 659-103 (Participants <=20 Years Old at Parent Study Baseline)
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
NA z-score
Standard Deviation NA
As pre-specified in analysis plan, due to less than 20 number of participants in the VX-659/TEZ/IVA - VX-659/TEZ/IVA category, the summary statistics were no longer applicable. Therefore, no BMI z-score efficacy data is available for this category.
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=371 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in Body Weight for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
4.8 kg
Standard Deviation 4.4
|
|
Absolute Change in Body Weight for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
4.3 kg
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in Body Weight for Participants From the Parent Study 659-103
TEZ/IVA - VX-659/TEZ/IVA
|
3.7 kg
Standard Deviation 4.9
|
|
Absolute Change in Body Weight for Participants From the Parent Study 659-103
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
3.2 kg
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. The analysis was planned to be reported separately for Placebo - VX-659/TEZ/IVA category (participants who received placebo in the parent study 659-102 and VX-659/TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-102 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=371 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for Participants From the Parent Study 659-102
Placebo - VX-659/TEZ/IVA
|
16.7 units on a scale
Standard Deviation 18.7
|
|
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for Participants From the Parent Study 659-102
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
19.7 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: From Baseline at Week 72 (Study 659-105)Population: OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, "number analyzed" signifies participants who were evaluable for the specified category.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. The analysis was planned to be reported separately for TEZ/IVA - VX-659/TEZ/IVA category (participants who received TEZ/IVA in the parent study 659-103 and VX-659-TEZ/IVA in the current study 659-105) and VX-659/TEZ/IVA - VX-659/TEZ/IVA category (participants who received VX-659/TEZ/IVA in both the parent study 659-103 and in the current study 659-105) as pre-specified in analysis plan. Baseline was defined as the parent study baseline.
Outcome measures
| Measure |
VX-659/TEZ/IVA TC
n=110 Participants
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Absolute Change in CFQ-R Respiratory Domain Score for Participants From the Parent Study 659-103
TEZ/IVA - VX-659/TEZ/IVA
|
17.1 units on a scale
Standard Deviation 18.2
|
|
Absolute Change in CFQ-R Respiratory Domain Score for Participants From the Parent Study 659-103
VX-659/TEZ/IVA - VX-659/TEZ/IVA
|
16.9 units on a scale
Standard Deviation 17.3
|
Adverse Events
VX-659/TEZ/IVA TC
Serious adverse events
| Measure |
VX-659/TEZ/IVA TC
n=481 participants at risk
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
3/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Constipation
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.2%
6/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Duodenitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Gastritis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
General disorders
Generalised oedema
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Biliary colic
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Cholangitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Immune system disorders
Anaphylactic reaction
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Bacterial disease carrier
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Bronchitis bacterial
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
H1N1 influenza
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
8.3%
40/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Influenza
|
0.83%
4/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Mastoiditis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Medical device site cellulitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Pneumonia
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Sepsis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Tonsillitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Urinary tract infection
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Vascular device infection
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Alanine aminotransferase increased
|
0.83%
4/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Aspartate aminotransferase increased
|
0.83%
4/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Pulmonary function test decreased
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Nervous system disorders
Seizure
|
0.42%
2/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Nervous system disorders
Syncope
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Product Issues
Device leakage
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Psychiatric disorders
Anxiety
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Psychiatric disorders
Breathing-related sleep disorder
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Psychiatric disorders
Delirium
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Psychiatric disorders
Suicidal ideation
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.62%
3/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Granulomatous pneumonitis
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
5/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.21%
1/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
Other adverse events
| Measure |
VX-659/TEZ/IVA TC
n=481 participants at risk
Participants from parent studies 659-102 or 659-103 were administered VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the TC treatment period for up to 96 weeks in the current study 659-105.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
21.6%
104/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.9%
38/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
43/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
42/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
37/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Nervous system disorders
Headache
|
10.6%
51/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.2%
126/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.1%
39/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.0%
53/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.6%
80/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
5.8%
28/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
40/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
27/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
14.3%
69/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
28/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
42/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
26/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
42/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Nausea
|
7.5%
36/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
27/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
General disorders
Fatigue
|
6.4%
31/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
General disorders
Pyrexia
|
11.6%
56/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
31.0%
149/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Influenza
|
8.3%
40/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Nasopharyngitis
|
20.2%
97/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
|
Infections and infestations
Sinusitis
|
6.2%
30/481 • From Day 1 up to 28 days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER