| Primary | Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 | CPET was used to assess change in exercise tolerance, as measured by VO2max. | The Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-3.5(-7.7 to 0.8)
- OG001-6.6(-11.3 to -2.0)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed effects model for repeated measure | | 0.3021 | | Least Squares Mean Difference | -3.2 | | | 2-Sided | 95 | -9.2 | 2.9 | | | | | Superiority | | |
|
| Secondary | Relative (Percent) Change From Baseline in Exercise Duration During CPET at Week 24 | Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Exercise Duration During CPET at Week 24 | Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | seconds | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in VO2max During CPET at Week 24 | CPET was used to assess change in exercise tolerance, as measured by VO2max. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | milliliter per kilogram per minute | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Oxygen Consumption (VO2) at Anaerobic Threshold at Week 24 | Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | milliliter per minute | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in VO2 at Anaerobic Threshold at Week 24 | Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Functional VO2 Gain at Week 24 | | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | milliliter per minute per watt | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Functional VO2 Gain at Week 24 | | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24 | | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | ratio | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24 | | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of predicted FEV1 | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Body Mass Index (BMI) at Week 24 | BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2). | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | kg/m^2 | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in BMI at Week 24 | BMI was defined as weight in kg divided by height in m^2. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24 | 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. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Number of Participants in Each Severity Category of Patient Health Questionnaire (PHQ-8) | 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. | FAS. Here "Number Analyzed" signifies those participants who were evaluated for this outcome at the specified time point. | Posted | | Number | | participants | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Number of Participants in Each Severity Category of Generalized Anxiety Disorder (GAD-7) Scores | 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. | FAS. Here "Number Analyzed" signifies those participants who were evaluated for this outcome at the specified time point. | Posted | | Number | | participants | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Daily Physical Activity Counts as Determined by Actigraphy at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activity counts. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | physical activity counts per day | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Physical Activity as Determined by Actigraphy at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activities. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Duration of Sleep Time at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | hours | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Duration of Sleep Time at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Absolute Change From Baseline in Time Above Sedentary Duration at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | hours | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Relative (Percent) Change From Baseline in Time Above Sedentary Duration at Week 24 | Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality. | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | | The Safety Set was defined as all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Day 1 up to Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks. | | OG001 | LUM/IVA | Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks. |
| |