Trial Outcomes & Findings for Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia (NCT NCT02871778)
NCT ID: NCT02871778
Last Updated: 2021-12-16
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included abnormal clinically significant findings for spirometry, clinical laboratory parameters, standard 12-lead electrocardiograms (ECGs), vital signs and pulse oximetry examinations. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 84 days that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both serious and non-serious TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Part A: From first dose of study drug up 84 days
Results posted on
2021-12-16
Participant Flow
This study consisted of Part A and Part B. Total of 123 participants were randomized to 1 of 4 sequences in Part A to receive study drug.
Participant milestones
| Measure |
Part A: VX-371 in Hypertonic Saline (HS), Then HS
Participants received 85 microgram (mcg) VX-371 diluted in 3 milliliter (mL) 4.2 percent (%) HS twice daily through oral nebulized inhalation from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: HS, Then VX-371 in HS
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: VX-371, Then Placebo
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: Placebo, Then VX-371
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part B: VX-371 in HS + Ivacaftor
Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: HS + Ivacaftor
Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: VX-371 + Ivacaftor
Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: Placebo + Ivacaftor
Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Treatment Period 1
STARTED
|
43
|
41
|
21
|
18
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
Safety Analysis Set
|
44
|
40
|
21
|
18
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
COMPLETED
|
40
|
37
|
18
|
16
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
NOT COMPLETED
|
3
|
4
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
STARTED
|
40
|
37
|
18
|
16
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
Safety Analysis Set
|
40
|
37
|
18
|
16
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
COMPLETED
|
37
|
35
|
17
|
15
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
NOT COMPLETED
|
3
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Part B: Treatment Period 3
STARTED
|
0
|
0
|
0
|
0
|
11
|
27
|
7
|
12
|
|
Part B: Treatment Period 3
Safety Analysis Set
|
0
|
0
|
0
|
0
|
11
|
27
|
7
|
12
|
|
Part B: Treatment Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
26
|
6
|
12
|
|
Part B: Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A: VX-371 in Hypertonic Saline (HS), Then HS
Participants received 85 microgram (mcg) VX-371 diluted in 3 milliliter (mL) 4.2 percent (%) HS twice daily through oral nebulized inhalation from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: HS, Then VX-371 in HS
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: VX-371, Then Placebo
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: Placebo, Then VX-371
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part B: VX-371 in HS + Ivacaftor
Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: HS + Ivacaftor
Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: VX-371 + Ivacaftor
Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: Placebo + Ivacaftor
Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Treatment Period 1
Adverse Event
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
Withdrawal of consent (not due to adverse event)
|
2
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
Noncompliant with study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
Other withdrawal criteria met
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 1
Wrong drug shipment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
Adverse Event
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A: Treatment Period 2
Non-Compliant with Study Drug
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia
Baseline characteristics by cohort
| Measure |
Part A: VX-371 in HS, Then HS
n=43 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS twice daily through oral nebulized inhalation from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: HS, Then VX-371 in HS
n=41 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: VX-371, Then Placebo
n=21 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Part A: Placebo, Then VX-371
n=18 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily from Day 1 through Day 29 in treatment period 1 followed by a 28 day washout period (from Day 29 through Day 56) and then received 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.19 years
STANDARD_DEVIATION 10.861 • n=93 Participants
|
27.98 years
STANDARD_DEVIATION 13.104 • n=4 Participants
|
27.62 years
STANDARD_DEVIATION 16.633 • n=27 Participants
|
24.33 years
STANDARD_DEVIATION 12.866 • n=483 Participants
|
27.80 years
STANDARD_DEVIATION 12.954 • n=36 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
78 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
106 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Part A: From first dose of study drug up 84 daysPopulation: Part A safety set included all participants who received at least 1 dose of study drug in Part A.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included abnormal clinically significant findings for spirometry, clinical laboratory parameters, standard 12-lead electrocardiograms (ECGs), vital signs and pulse oximetry examinations. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 84 days that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=81 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=80 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=37 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=36 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
52 Participants
|
46 Participants
|
22 Participants
|
23 Participants
|
|
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Part B: Day 85 up to 28 days after last dose of study drug (56 days)Population: Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included abnormal clinically significant findings for spirometry, clinical laboratory parameters, standard 12-lead electrocardiograms (ECGs), vital signs and pulse oximetry examinations. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=11 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=27 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=7 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=12 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
5 Participants
|
17 Participants
|
5 Participants
|
9 Participants
|
|
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Study Baseline, Day 29 of each treatment periodPopulation: Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=78 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=75 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=34 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=34 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29
|
0.989 Percentage of predicted FEV1
Standard Error 0.7097
|
-0.531 Percentage of predicted FEV1
Standard Error 0.7202
|
-0.491 Percentage of predicted FEV1
Standard Error 1.0736
|
-1.329 Percentage of predicted FEV1
Standard Error 1.0730
|
PRIMARY outcome
Timeframe: Study Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=10 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=26 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=12 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29
|
4.721 Percentage of predicted FEV1
Standard Error 1.9314
|
1.722 Percentage of predicted FEV1
Standard Error 1.1976
|
-0.592 Percentage of predicted FEV1
Standard Error 2.5011
|
-0.965 Percentage of predicted FEV1
Standard Error 1.8388
|
PRIMARY outcome
Timeframe: Part B Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Part B baseline was defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of ivacaftor in Part B and after the last dose in Period 2.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=10 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=26 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=12 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Absolute Change From Part B Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29
|
2.528 Percentage of predicted FEV1
Standard Error 1.8633
|
1.678 Percentage of predicted FEV1
Standard Error 1.1414
|
-1.018 Percentage of predicted FEV1
Standard Error 2.3797
|
-2.040 Percentage of predicted FEV1
Standard Error 1.7427
|
SECONDARY outcome
Timeframe: Study Baseline, Day 29 of Part APopulation: Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, "overall number of participants analyzed" signifies adult participants evaluable for this outcome measure.
QOL- PCD adult version has following 10 domains: lower respiratory symptoms, emotional functioning, treatment burden, role, social functioning, vitality, health perception, upper respiratory symptoms, physical functioning and hearing symptoms. The total numbers of items in the lower respiratory symptoms domain are 6 in the questionnaire for adults. All items are scored using a 4-point Likert scale. Scaled score calculated as: \[Sum of scores - (n\*1)\] / \[(n\*4) - (n\*1)\]\*100. Where 'n' is the number of questions in domain. The total score range is from 0-100, where higher score indicates greater improvement. Change from study baseline \>0 indicated improvement. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=46 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=45 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=17 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=15 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part A: Change From Study Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29
|
4.23 score on a scale
Standard Deviation 18.076
|
3.58 score on a scale
Standard Deviation 16.715
|
0.98 score on a scale
Standard Deviation 12.915
|
7.04 score on a scale
Standard Deviation 16.728
|
SECONDARY outcome
Timeframe: Study Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies adult participants evaluable for this outcome measure.
QOL- PCD adult version has following 10 domains: lower respiratory symptoms, emotional functioning, treatment burden, role, social functioning, vitality, health perception, upper respiratory symptoms, physical functioning and hearing symptoms. The total numbers of items in the lower respiratory symptoms domain are 6 in the questionnaire for adults. All items are scored using a 4-point Likert scale. Scaled score calculated as: \[Sum of scores - (n\*1)\] / \[(n\*4) - (n\*1)\]\*100. Where 'n' is the number of questions in domain. The total score range is from 0-100, where higher score indicates greater improvement. Change from study baseline \>0 indicated improvement. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=16 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=3 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=6 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Change From Study Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29
|
16.67 score on a scale
Standard Deviation 14.487
|
1.39 score on a scale
Standard Deviation 17.153
|
7.41 score on a scale
Standard Deviation 3.208
|
-5.56 score on a scale
Standard Deviation 23.307
|
SECONDARY outcome
Timeframe: Part B Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies adult participants evaluable for this outcome measure.
QOL- PCD adult version has following 10 domains: lower respiratory symptoms, emotional functioning, treatment burden, role, social functioning, vitality, health perception, upper respiratory symptoms, physical functioning and hearing symptoms. The total numbers of items in the lower respiratory symptoms domain are 6 in the questionnaire for adults. All items are scored using a 4-point Likert scale. Scaled score calculated as: \[Sum of scores - (n\*1)\] / \[(n\*4) - (n\*1)\]\*100. Where 'n' is the number of questions in domain. The total score range is from 0-100, where higher score indicates greater improvement. Change from Part B baseline \>0 indicated improvement. Part B baseline was defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of ivacaftor in Part B and after the last dose in Period 2.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=16 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=3 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=6 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Change From Part B Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29
|
11.11 score on a scale
Standard Deviation 15.713
|
1.39 score on a scale
Standard Deviation 19.928
|
5.56 score on a scale
Standard Deviation 16.667
|
-7.41 score on a scale
Standard Deviation 10.344
|
SECONDARY outcome
Timeframe: Study Baseline, Day 29 of Part APopulation: Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, "overall number of participants analyzed" signifies participants \>=16 years of age evaluable for this outcome measure.
SGRQ measured health-related quality of life among participants with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). Total scores range from 0 to 100. Higher score reflected worse quality of life. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=63 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=62 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=28 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=25 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part A: Change From Study Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged Greater Than or Equals to (>=) 16 Years at Day 29
|
-1.28 score on a scale
Standard Deviation 8.452
|
-2.17 score on a scale
Standard Deviation 6.462
|
1.54 score on a scale
Standard Deviation 8.576
|
-1.52 score on a scale
Standard Deviation 9.082
|
SECONDARY outcome
Timeframe: Study Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies participants \>=16 years of age evaluable for this outcome measure.
SGRQ measured health-related quality of life among participants with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). Total scores range from 0 to 100. Higher score reflected worse quality of life. The study baseline is defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of study drug in the study.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=25 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=5 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=8 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Change From Study Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged >=16 Years at Day 29
|
-1.69 score on a scale
Standard Deviation 7.442
|
-6.87 score on a scale
Standard Deviation 6.571
|
0.78 score on a scale
Standard Deviation 5.879
|
4.52 score on a scale
Standard Deviation 16.995
|
SECONDARY outcome
Timeframe: Part B Baseline, Day 29 of Part BPopulation: Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, "overall number of participants analyzed" signifies participants \>=16 years of age evaluable for this outcome measure.
SGRQ measured health-related quality of life among participants with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). Total scores range from 0 to 100. Higher score reflected worse quality of life. Part B baseline was defined as the most recent non-missing measurement (scheduled or unscheduled) collected before the first dose of ivacaftor in Part B and after the last dose in Period 2.
Outcome measures
| Measure |
Part A: VX-371 in HS
n=6 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=25 Participants
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=5 Participants
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=8 Participants
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
|---|---|---|---|---|
|
Part B: Change From Part B Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged >=16 Years at Day 29
|
-3.90 score on a scale
Standard Deviation 4.331
|
-2.64 score on a scale
Standard Deviation 6.575
|
0.97 score on a scale
Standard Deviation 7.561
|
3.19 score on a scale
Standard Deviation 11.649
|
Adverse Events
Part A: VX-371 in HS
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Part A: HS
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Part A: VX-371
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Part B: VX-371 in HS + Ivacaftor
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: HS + Ivacaftor
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B: VX-371 + Ivacaftor
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Placebo + Ivacaftor
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: VX-371 in HS
n=81 participants at risk
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=80 participants at risk
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=37 participants at risk
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=36 participants at risk
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part B: VX-371 in HS + Ivacaftor
n=11 participants at risk
Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: HS + Ivacaftor
n=27 participants at risk
Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: VX-371 + Ivacaftor
n=7 participants at risk
Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: Placebo + Ivacaftor
n=12 participants at risk
Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
1.2%
1/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.8%
1/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.7%
1/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
Other adverse events
| Measure |
Part A: VX-371 in HS
n=81 participants at risk
Participants received 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: HS
n=80 participants at risk
Participants received 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: VX-371
n=37 participants at risk
Participants received 85 mcg VX-371 diluted in 3 mL 0.17% Saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part A: Placebo
n=36 participants at risk
Participants received 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days in either treatment period 1 or 2.
|
Part B: VX-371 in HS + Ivacaftor
n=11 participants at risk
Participants who were on 85 mcg VX-371 diluted in 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: HS + Ivacaftor
n=27 participants at risk
Participants who were on 3 mL 4.2% HS through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: VX-371 + Ivacaftor
n=7 participants at risk
Participants who were on 85 mcg VX-371 diluted in 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
Part B: Placebo + Ivacaftor
n=12 participants at risk
Participants who were on 3 mL 0.17% saline (placebo) through oral nebulized inhalation twice daily for 28 days (from Day 57 through Day 85) in treatment period 2 continued their inhaled study drug regimen from Treatment Period 2 and also received ivacaftor 150 mg tablet twice daily for 28 days (from Day 85 through Day 113) in treatment period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.4%
2/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Haemophilus test positive
|
1.2%
1/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.1%
3/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.8%
1/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Moraxella test positive
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.1%
3/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Lipase increased
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
16.7%
2/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Amylase increased
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Investigations
Weight decreased
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
11/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
10.0%
8/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
10.8%
4/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
3/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
27.3%
3/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.4%
2/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.9%
8/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.8%
3/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.1%
3/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.4%
2/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
28.6%
2/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
5/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.8%
3/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.7%
1/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.8%
1/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
6.2%
5/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.7%
1/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
11.1%
3/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.7%
1/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Nervous system disorders
Dysgeusia
|
9.9%
8/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.8%
3/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.1%
3/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.8%
1/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Nervous system disorders
Headache
|
9.9%
8/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.8%
7/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.4%
2/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
16.7%
6/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
27.3%
3/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.8%
4/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
25.0%
3/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Eye disorders
Vision blurred
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
General disorders
Chest discomfort
|
6.2%
5/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.5%
6/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.8%
1/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
11.1%
3/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
General disorders
Pyrexia
|
4.9%
4/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.4%
2/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.6%
2/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
11.1%
3/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
General disorders
Fatigue
|
2.5%
2/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.0%
4/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.4%
2/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.6%
2/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
18.2%
2/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.7%
1/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
2.7%
1/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.6%
2/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
3.7%
1/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
18.5%
5/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.4%
2/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
7.4%
2/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
5.6%
2/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
4/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
1.2%
1/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
3/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
11.1%
3/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
8.3%
1/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
14.3%
1/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/81 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/80 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/37 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/36 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
9.1%
1/11 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/27 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/7 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
0.00%
0/12 • Part A: From first dose of study drug up to 84 days; Part B: Day 85 up to 28 days after last dose of study drug (56 days)
Part A safety set included all participants who received at least 1 dose of study drug in Part A. Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place