Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation (NCT NCT02516410)
NCT ID: NCT02516410
Last Updated: 2018-06-12
Results Overview
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
COMPLETED
PHASE3
168 participants
Baseline, Through Week 12
2018-06-12
Participant Flow
The study was conducted across 38 sites in 7 countries.
A total of 168 participants were randomized and treated in the study.
Participant milestones
| Measure |
Placebo
Placebo matched to VX-661 plus Ivacaftor (IVA, VX-770) fixed dose combination (FDC) tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
VX-661 100 milligram (mg) plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
83
|
|
Overall Study
COMPLETED
|
85
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to VX-661 plus Ivacaftor (IVA, VX-770) fixed dose combination (FDC) tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
VX-661 100 milligram (mg) plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
26.2 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
26.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Through Week 12Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=82 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12
|
-0.1 Percentage of predicted FEV1
Standard Error 0.6
|
1 Percentage of predicted FEV1
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline, Through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12
|
3.8 Units on a scale
Interval 1.1 to 6.4
|
5.9 Units on a scale
Interval 3.2 to 8.5
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Number of Pulmonary Exacerbation Events
|
23 Pulmonary exacerbation events
|
22 Pulmonary exacerbation events
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Total number of days on study is equal to the Week 12 date or the last dose date (whichever occurs last) minus first dose date plus 1. The total number of years (48 weeks) on study is equal to the total number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Number of Pulmonary Exacerbation Events Per Year
|
0.98 Pulmonary exacerbation events per year
|
0.97 Pulmonary exacerbation events per year
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.
BMI was defined as weight in kilogram (kg) divided by height\*height in square meter (m\^2).
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=82 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in Body Mass Index (BMI) at Week 12
|
0.22 Kg/m^2
Interval 0.07 to 0.36
|
0.14 Kg/m^2
Interval -0.01 to 0.28
|
SECONDARY outcome
Timeframe: Baseline, Through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=82 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Relative Change From Baseline in Percent Predicted FEV1 Through Week 12
|
0.1 Percent Change
Interval -2.1 to 2.3
|
2.1 Percent Change
Interval -0.1 to 4.3
|
SECONDARY outcome
Timeframe: Baseline, Through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=79 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in Sweat Chloride Through Week 12
|
-1.2 Millimole per liter (mmol/L)
Interval -3.1 to 0.7
|
-4.7 Millimole per liter (mmol/L)
Interval -6.6 to -2.8
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Number of Participants With at Least One Pulmonary Exacerbation Through Week 12
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis population included all randomized participants who received at least 1 dose of study drug and were \<20 years of age at the time of screening.
Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from infinity to +infinity; where 0: same mean, \>0: a greater mean, and \<0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age Z-score (BMI z-score). BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the paediatric population.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=25 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in BMI Z-score at Week 12 (in Participants Less Than [<] 20 Years Old at the Time of Screening)
|
0.07 Z-score
Interval -0.05 to 0.19
|
0.02 Z-score
Interval -0.09 to 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=82 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Absolute Change From Baseline in Body Weight at Week 12
|
0.7 Kilograms (kg)
Interval 0.3 to 1.1
|
0.6 Kilograms (kg)
Interval 0.2 to 1.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: Safety Set included all participants who received at least 1 dose of the study drug.
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 16 was considered treatment-emergent.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 Participants
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with any AEs
|
68 Participants
|
64 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with any SAEs
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Pre-morning dose on Week 2, Week 4, Week 8 and Week 12Population: Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively.
This outcome was not planned to be assessed in Placebo arm.
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 2: VX-661
|
1880 nanogram per milliliter (ng/mL)
Standard Deviation 1230
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 2: M1 VX-661
|
4600 nanogram per milliliter (ng/mL)
Standard Deviation 1430
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 2: IVA
|
831 nanogram per milliliter (ng/mL)
Standard Deviation 607
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 2: M1-IVA
|
1580 nanogram per milliliter (ng/mL)
Standard Deviation 879
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 4: VX-661
|
1780 nanogram per milliliter (ng/mL)
Standard Deviation 1010
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 4: M1 VX-661
|
4420 nanogram per milliliter (ng/mL)
Standard Deviation 1340
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 4: IVA
|
770 nanogram per milliliter (ng/mL)
Standard Deviation 596
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 4: M1-IVA
|
1500 nanogram per milliliter (ng/mL)
Standard Deviation 898
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 8: VX-661
|
1920 nanogram per milliliter (ng/mL)
Standard Deviation 2170
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 8: M1 VX-661
|
4330 nanogram per milliliter (ng/mL)
Standard Deviation 1980
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 8: IVA
|
747 nanogram per milliliter (ng/mL)
Standard Deviation 745
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 8: M1-IVA
|
1370 nanogram per milliliter (ng/mL)
Standard Deviation 1070
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 12: VX-661
|
1700 nanogram per milliliter (ng/mL)
Standard Deviation 1220
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 12: M1 VX-661
|
4290 nanogram per milliliter (ng/mL)
Standard Deviation 1730
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 12: IVA
|
776 nanogram per milliliter (ng/mL)
Standard Deviation 690
|
—
|
|
Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)
Week 12: M1-IVA
|
1620 nanogram per milliliter (ng/mL)
Standard Deviation 1160
|
—
|
Adverse Events
Placebo
VX-661/IVA
Serious adverse events
| Measure |
Placebo
n=85 participants at risk
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 participants at risk
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Investigations
Pulmonary function test decreased
|
1.2%
1/85 • Baseline up to Week 16
|
0.00%
0/83 • Baseline up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/85 • Baseline up to Week 16
|
1.2%
1/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/85 • Baseline up to Week 16
|
2.4%
2/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.2%
1/85 • Baseline up to Week 16
|
0.00%
0/83 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/85 • Baseline up to Week 16
|
3.6%
3/83 • Baseline up to Week 16
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
14.1%
12/85 • Baseline up to Week 16
|
7.2%
6/83 • Baseline up to Week 16
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/85 • Baseline up to Week 16
|
1.2%
1/83 • Baseline up to Week 16
|
|
Infections and infestations
Influenza
|
1.2%
1/85 • Baseline up to Week 16
|
0.00%
0/83 • Baseline up to Week 16
|
|
Infections and infestations
Sinusitis
|
1.2%
1/85 • Baseline up to Week 16
|
0.00%
0/83 • Baseline up to Week 16
|
Other adverse events
| Measure |
Placebo
n=85 participants at risk
Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
|
VX-661/IVA
n=83 participants at risk
VX-661 100 mg plus IVA 150 mg FDC tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.8%
27/85 • Baseline up to Week 16
|
22.9%
19/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
6/85 • Baseline up to Week 16
|
9.6%
8/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
8/85 • Baseline up to Week 16
|
8.4%
7/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
14.1%
12/85 • Baseline up to Week 16
|
8.4%
7/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
7/85 • Baseline up to Week 16
|
6.0%
5/83 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
6/85 • Baseline up to Week 16
|
6.0%
5/83 • Baseline up to Week 16
|
|
Nervous system disorders
Headache
|
8.2%
7/85 • Baseline up to Week 16
|
6.0%
5/83 • Baseline up to Week 16
|
|
General disorders
Fatigue
|
4.7%
4/85 • Baseline up to Week 16
|
12.0%
10/83 • Baseline up to Week 16
|
|
General disorders
Pyrexia
|
5.9%
5/85 • Baseline up to Week 16
|
6.0%
5/83 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
7.1%
6/85 • Baseline up to Week 16
|
7.2%
6/83 • Baseline up to Week 16
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
17.6%
15/85 • Baseline up to Week 16
|
20.5%
17/83 • Baseline up to Week 16
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
5/85 • Baseline up to Week 16
|
2.4%
2/83 • Baseline up to Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: PI is free to publish results of the study after (1)first multi-center publication, (2)if sponsor elects not to publish the results, or (3)18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications
- Publication restrictions are in place
Restriction type: OTHER