Trial Outcomes & Findings for Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older (NCT NCT04183790)
NCT ID: NCT04183790
Last Updated: 2025-05-18
Results Overview
COMPLETED
PHASE3
64 participants
From Baseline up to Week 196
2025-05-18
Participant Flow
The study was conducted in two parts, Part A and Part B. Participants of both Parts A and B received the same treatment (ELX,TEZ,IVA). Therefore, results data were planned to be collected and analyzed for the overall population of the study and not for separate parts.
Participants from parent study VX18-445-106 Part B (NCT03691779) were enrolled in this study. A total of 64 participants were enrolled in this open label extension study.
Participant milestones
| Measure |
ELX/TEZ/IVA
Participants greater than or equal to (≥) 6 years and less than (\<) 12 years of age and weighing \<30 kilograms (kg) received ELX (elexacaftor) 100 milligram (mg) once daily (qd) /TEZ (tezacaftor) 50 mg qd/IVA (ivacaftor) 75 mg every 12 hours (q12h) and those weighing (≥) 30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/ TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
Additional Participants for Cumulative Triple Combination (TC) Efficacy Set
This reporting arm represents the two additional participants in Cumulative TC Efficacy Set 106/107 from parent study 106 which were not enrolled in this study, but were included in the Cumulative TC efficacy 106/107 analysis set.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
2
|
|
Overall Study
Part A Completed
|
60
|
0
|
|
Overall Study
Rollover to Part B
|
48
|
0
|
|
Overall Study
Cumulative TC Efficacy Set 106/107
|
64
|
2
|
|
Overall Study
COMPLETED
|
39
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
2
|
Reasons for withdrawal
| Measure |
ELX/TEZ/IVA
Participants greater than or equal to (≥) 6 years and less than (\<) 12 years of age and weighing \<30 kilograms (kg) received ELX (elexacaftor) 100 milligram (mg) once daily (qd) /TEZ (tezacaftor) 50 mg qd/IVA (ivacaftor) 75 mg every 12 hours (q12h) and those weighing (≥) 30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/ TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
Additional Participants for Cumulative Triple Combination (TC) Efficacy Set
This reporting arm represents the two additional participants in Cumulative TC Efficacy Set 106/107 from parent study 106 which were not enrolled in this study, but were included in the Cumulative TC efficacy 106/107 analysis set.
|
|---|---|---|
|
Overall Study
Participants did not rollover to Part B
|
12
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
6
|
0
|
|
Overall Study
Commercial drug is available for participant
|
6
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Not enrolled in 107 study
|
0
|
2
|
Baseline Characteristics
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older
Baseline characteristics by cohort
| Measure |
ELX/TEZ/IVA
n=64 Participants
Participants ≥6 years and \<12 years of age and weighing \<30 kg received ELX 100 mg qd /TEZ 50 mg qd/IVA 75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Age, Continuous
|
9.3 years
STANDARD_DEVIATION 1.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
56 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not collected per local regulations
|
8 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
More than one Race
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 196Population: OLE Safety Set was defined as all subjects who received at least 1 dose of study drug in this OLE study. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA arm irrespective of Part A and B separately.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=64 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
64 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
7 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: Open label Extension Full Analysis Set (OLE FAS) included all enrolled participants who have received at least 1 dose of study drug in the OLE study. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=27 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
9.6 percent predicted FEV1
Interval 5.4 to 13.7
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=35 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Sweat Chloride (SwCl)
|
-57.9 millimole per liter (mmol/L)
Interval -63.3 to -52.5
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=36 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
|
10.0 units on a scale
Interval 6.9 to 13.0
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
BMI was defined as weight in kg divided by squared height in meters (m\^2).
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Body Mass Index (BMI)
|
3.60 kg/m^2
Interval 2.98 to 4.23
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
BMI was defined as weight in kg divided by squared height in meters (m\^2). The z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in BMI-for-age Z-score
|
0.39 z-score
Interval 0.19 to 0.59
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: The Cumulative TC Set includes participants who enrolled and received at least one dose of study drug during the parent study (445-106 Part B) and/or received at least one dose of study drug during this OLE Study. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who evaluated for this specific outcome measure.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=66 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Number of Participants With Pulmonary Exacerbations (PEx) for 106/107
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: The Cumulative TC Set. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
The total number of CF related hospitalization (Planned + Unplanned) events across all participants were reported.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=66 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Number of CF-related Hospitalizations for 106/107
|
5 hospitalizations
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=25 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Lung Clearance Index 2.5 (LCI 2.5)
|
-2.33 index
Interval -2.87 to -1.79
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Weight
|
19.9 Kilogram (kg)
Interval 18.1 to 21.7
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
The z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Weight-for-age Z-score
|
0.38 z-score
Interval 0.2 to 0.55
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Height
|
23.1 centimeters (cm)
Interval 21.6 to 24.6
|
SECONDARY outcome
Timeframe: From Baseline up to Week 192Population: OLE FAS. Data for this outcome measure was planned to be collected and analyzed for the overall ELX/TEZ/IVA TC arm irrespective of Part A and B separately. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
The z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=39 Participants
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks.
|
|---|---|
|
Absolute Change in Height-for-age Z-score
|
0.04 z-score
Interval -0.12 to 0.19
|
Adverse Events
ELX/TEZ/IVA
Serious adverse events
| Measure |
ELX/TEZ/IVA
n=64 participants at risk
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
4.7%
3/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Immune system disorders
Anaphylactic reaction
|
1.6%
1/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
3.1%
2/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
1.6%
1/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
1.6%
1/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
Other adverse events
| Measure |
ELX/TEZ/IVA
n=64 participants at risk
Participants ≥6 years and \<12 years of age and weighing \<30kg received ELX 100 mg qd /TEZ 50 mg qd/IVA75 mg q12h and those weighing ≥30 kg received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for up to 192 weeks
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
7.8%
5/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
4/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.9%
14/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Constipation
|
15.6%
10/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
10/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
6/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Gastrointestinal disorders
Vomiting
|
26.6%
17/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
General disorders
Fatigue
|
15.6%
10/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
General disorders
Pyrexia
|
43.8%
28/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
COVID-19
|
28.1%
18/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Ear infection
|
6.2%
4/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Hordeolum
|
14.1%
9/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
12.5%
8/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Influenza
|
10.9%
7/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
10/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.8%
5/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Sinusitis
|
9.4%
6/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.7%
19/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.9%
7/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
6.2%
4/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
6/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Investigations
Aspartate aminotransferase increased
|
7.8%
5/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Investigations
Bacterial test positive
|
10.9%
7/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Investigations
SARS-CoV-2 test positive
|
12.5%
8/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Nervous system disorders
Headache
|
40.6%
26/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
62.5%
40/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
4/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
35.9%
23/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
37.5%
24/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.2%
11/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
32.8%
21/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.2%
4/64 • Day 1 Up to Week 196
The OLE Safety Set is defined as all participants who received at least 1 dose of study drug in the OLE study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place