Clinical Trial Results:
A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation.
Summary
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EudraCT number |
2016-000066-34 |
Trial protocol |
GB |
Global end of trial date |
23 Oct 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Feb 2019
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First version publication date |
02 Feb 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VX15-809-112
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02875366 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Vertex Pharmaceuticals Incorporated
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Sponsor organisation address |
50 Northern Avenue, Boston, Massachusetts, United States, 02210-1862
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Public contact |
Clinical Trials and Medical Info, Medical Monitor, Vertex Pharmaceuticals Incorporated, 001 617-341-6777, medicalinfo@vrtx.com
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Scientific contact |
Clinical Trials and Medical Info, Medical Monitor, Vertex Pharmaceuticals Incorporated, 001 617-341-6777, medicalinfo@vrtx.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Nov 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Sep 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.
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Protection of trial subjects |
The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Australia: 67
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Country: Number of subjects enrolled |
United Kingdom: 3
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Worldwide total number of subjects |
70
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EEA total number of subjects |
3
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
22
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Adults (18-64 years) |
48
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
Subjects were randomized at 13 sites in Australia and the UK. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Subjects received placebo matched to lumacaftor (LUM)/ivacaftor (IVA) fixed-dose combination every 12 hours (q12h) for 24 weeks. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo (matched to LUM/IVA)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received placebo matched to LUM/IVA fixed-dose combination q12h for 24 weeks.
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Arm title
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LUM/IVA | ||||||||||||||||||
Arm description |
Subjects received LUM 400 mg/IVA 250 mg fixed-dose combination q12h for 24 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
LUM/IVA
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Investigational medicinal product code |
VX-809/VX-770
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Other name |
Lumacaftor/Ivacaftor
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received LUM 400 mg/IVA 250 mg fixed-dose combination q12h for 24 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo matched to lumacaftor (LUM)/ivacaftor (IVA) fixed-dose combination every 12 hours (q12h) for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LUM/IVA
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Reporting group description |
Subjects received LUM 400 mg/IVA 250 mg fixed-dose combination q12h for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo matched to lumacaftor (LUM)/ivacaftor (IVA) fixed-dose combination every 12 hours (q12h) for 24 weeks. | ||
Reporting group title |
LUM/IVA
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Reporting group description |
Subjects received LUM 400 mg/IVA 250 mg fixed-dose combination q12h for 24 weeks. |
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End point title |
Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 | ||||||||||||
End point description |
CPET was used to assess change in exercise tolerance, as measured by VO2max. The Full Analysis Set (FAS) included all randomized subjects who received any amount of study drug. Here “Number of subjects analysed” signifies those subjects who were evaluated for this end point.
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End point type |
Primary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3021 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least squares mean difference | ||||||||||||
Point estimate |
-3.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-9.2 | ||||||||||||
upper limit |
2.9 |
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End point title |
Relative (Percent) Change From Baseline in Exercise Duration During CPET at Week 24 | ||||||||||||
End point description |
Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.1894 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-3.2
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-8 | ||||||||||||
upper limit |
1.6 |
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End point title |
Absolute Change From Baseline in Exercise Duration During CPET at Week 24 | ||||||||||||
End point description |
Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
LUM/IVA v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2328 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-15.3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-40.8 | ||||||||||||
upper limit |
10.1 |
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End point title |
Absolute Change From Baseline in VO2max During CPET at Week 24 | ||||||||||||
End point description |
CPET was used to assess change in exercise tolerance, as measured by VO2max. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.1203 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-1.4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.1 | ||||||||||||
upper limit |
0.4 |
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End point title |
Absolute Change From Baseline in Oxygen Consumption (VO2) at Anaerobic Threshold at Week 24 | ||||||||||||
End point description |
Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0439 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-149.6
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-295 | ||||||||||||
upper limit |
-4.2 |
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End point title |
Relative (Percent) Change From Baseline in VO2 at Anaerobic Threshold at Week 24 | ||||||||||||
End point description |
Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate. Analysis was performed on FAS. Here, number of subjects analyzed signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2237 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-7.5
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-19.8 | ||||||||||||
upper limit |
4.7 |
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End point title |
Absolute Change From Baseline in Functional VO2 Gain at Week 24 | ||||||||||||
End point description |
Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0226 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.6
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.12 | ||||||||||||
upper limit |
-0.09 |
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End point title |
Relative (Percent) Change From Baseline in Functional VO2 Gain at Week 24 | ||||||||||||
End point description |
Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0613 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-6.32
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-12.94 | ||||||||||||
upper limit |
0.31 |
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End point title |
Absolute Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24 | ||||||||||||
End point description |
Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.6409 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.3
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.9 | ||||||||||||
upper limit |
1.5 |
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End point title |
Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24 | ||||||||||||
End point description |
Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Statistical analysis description |
Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24. Analysis was performed using MMRM model.
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Comparison groups |
Placebo v LUM/IVA
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||||||||||||
Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.5889 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
1
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||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.7 | ||||||||||||
upper limit |
4.7 |
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End point title |
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24 | ||||||||||||
End point description |
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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||||||||||||
End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
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||||||||||||
Number of subjects included in analysis |
62
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||||||||||||
Analysis specification |
Pre-specified
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||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.146 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
3.4
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||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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||||||||||||
lower limit |
-1.2 | ||||||||||||
upper limit |
8.1 |
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End point title |
Relative (Percent) Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24 | ||||||||||||
End point description |
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
|
||||||||||||
Number of subjects included in analysis |
62
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.3091 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
3.5
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||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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||||||||||||
lower limit |
-3.4 | ||||||||||||
upper limit |
10.4 |
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End point title |
Absolute Change From Baseline in Body Mass Index (BMI) at Week 24 | ||||||||||||
End point description |
BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2). Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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||||||||||||
End point timeframe |
Baseline, Week 24
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||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
|
||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.3961 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.3 | ||||||||||||
upper limit |
0.6 |
|
|||||||||||||
End point title |
Relative (Percent) Change From Baseline in BMI at Week 24 | ||||||||||||
End point description |
BMI was defined as weight in kg divided by height in m^2. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
LUM/IVA v Placebo
|
||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.3905 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.9
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.2 | ||||||||||||
upper limit |
3.1 |
|
|||||||||||||
End point title |
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24 | ||||||||||||
End point description |
The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v LUM/IVA
|
||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority [1] | ||||||||||||
P-value |
= 0.1257 | ||||||||||||
Method |
Mixed effects model for repeated measure | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
6.2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.8 | ||||||||||||
upper limit |
14.1 | ||||||||||||
Notes [1] - Analysis was performed using MMRM model. |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects in Each Severity Category of Patient Health Questionnaire (PHQ-8) | ||||||||||||||||||||||||||||||||||||||||||
End point description |
The PHQ-8 is an eight item self-reported measure of depression. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual eight items and ranges from 0 to 24, with higher scores indicating more severe depression symptoms. Total score of 0 to 5 indicates none to minimal depression, 6 to 10 indicates mild depression, 11 to 15 indicates moderate depression, 16 to 20 indicates moderately severe depression and 21 to 24 indicates severe depression. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Number of Subjects in Each Severity Category of Generalized Anxiety Disorder (GAD-7) Scores | ||||||||||||||||||||||||||||||||||||
End point description |
The GAD-7 is a seven item, self-reported measurement of GAD severity. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual seven items and ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. Total score of 0 to 5 indicates none to minimal anxiety, 6 to 10 indicates mild anxiety, 11 to 15 indicates moderate anxiety, 16 to 21 indicates severe anxiety. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Absolute Change From Baseline in Physical Activity as Determined by Actigraphy at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activities. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Relative (Percent) Change From Baseline in Physical Activity as Determined by Actigraphy at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activities. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Absolute Change From Baseline in Duration of Sleep Time at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Relative (Percent) Change From Baseline in Duration of Sleep Time at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Absolute Change From Baseline in Time Above Sedentary Duration at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Relative (Percent) Change From Baseline in Time Above Sedentary Duration at Week 24 | ||||||||||||
End point description |
Subjects were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality. Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | ||||||||||||||||||
End point description |
Analysis was performed on FAS. Here, "Number of subjects analysed" signifies subjects who were evaluable for this end point.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline to Week 24
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Day 1 up to Week 28
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LUM/IVA
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |