Trial Outcomes & Findings for EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients (NCT NCT02443688)
NCT ID: NCT02443688
Last Updated: 2019-09-04
Results Overview
Difference from Placebo in absolute change from Baseline at Week 48 was assessed for FEV1 percent predicted.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
100 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
|
Matching Placebo
Once daily oral capsule for 48 weeks
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
67
|
|
Overall Study
COMPLETED
|
54
|
58
|
55
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
12
|
Reasons for withdrawal
| Measure |
100 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
|
Matching Placebo
Once daily oral capsule for 48 weeks
Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
4
|
|
Overall Study
Non-compliance with study drug
|
1
|
2
|
4
|
|
Overall Study
Sponsor Request
|
2
|
1
|
0
|
Baseline Characteristics
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
Baseline characteristics by cohort
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
Placebo
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
187 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 3.24 • n=99 Participants
|
23.7 years
STANDARD_DEVIATION 3.64 • n=107 Participants
|
23.2 years
STANDARD_DEVIATION 3.38 • n=206 Participants
|
23.7 years
STANDARD_DEVIATION 3.43 • n=7 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
101 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
192 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
On cystic fibrosis transmembrane conductance regulator (CFTR) Modulator Therapy: Yes
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
On CFTR Modulator Therapy: No
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
137 Participants
n=7 Participants
|
|
Number of Pulmonary Exacerbations in the year prior to Screening
|
2.32 pulmonary Exacerbations/year
STANDARD_DEVIATION 1.947 • n=99 Participants
|
2.13 pulmonary Exacerbations/year
STANDARD_DEVIATION 1.466 • n=107 Participants
|
1.94 pulmonary Exacerbations/year
STANDARD_DEVIATION 1.357 • n=206 Participants
|
2.13 pulmonary Exacerbations/year
STANDARD_DEVIATION 1.609 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The primary analysis was based upon the pooled results of the 100mg and 50mg doses.
Difference from Placebo in absolute change from Baseline at Week 48 was assessed for FEV1 percent predicted.
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)
|
-1.30 FEV1 percent predicted
Interval -3.22 to 0.62
|
-3.76 FEV1 percent predicted
Interval -5.65 to -1.86
|
-2.53 FEV1 percent predicted
Interval -3.88 to -1.18
|
-2.69 FEV1 percent predicted
Interval -4.63 to -0.75
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Number of Pulmonary Exacerbations Through 48 Weeks
|
1.57 pulmonary exacerbations per year
Interval 1.22 to 2.02
|
1.46 pulmonary exacerbations per year
Interval 1.13 to 1.89
|
1.51 pulmonary exacerbations per year
Interval 1.26 to 1.81
|
1.56 pulmonary exacerbations per year
Interval 1.21 to 2.01
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Hazard Ratio of pulmonary exacerbation versus placebo for all subjects. Pulmonary exacerbations are defined as treatment with oral, inhaled, or intravenous antibiotic(s) for ≥4 of symptoms/signs per the modified Fuchs criteria.
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Hazard Ratio Pulmonary Exacerbation While in the Study
|
0.88 hazard ratio
Interval 0.576 to 1.339
|
0.86 hazard ratio
Interval 0.563 to 1.308
|
0.87 hazard ratio
Interval 0.605 to 1.246
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment.
Subjects who did not experience a protocol-defined pulmonary exacerbation during the study
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Subjects Without a Pulmonary Exacerbation While in the Study
|
25 Participants
|
26 Participants
|
51 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Percent change from Baseline for ppFEV1 at 48 weeks was assessed.
Outcome measures
| Measure |
100 mg CTX-4430
n=59 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=59 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=118 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=57 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Relative Change (Percent Change) From Baseline in ppFEV1
|
-2.38 percent change from baseline
Interval -5.37 to 0.6
|
-4.81 percent change from baseline
Interval -7.84 to -1.79
|
-3.60 percent change from baseline
Interval -5.72 to -1.47
|
-3.40 percent change from baseline
Interval -6.59 to -0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Outcome measures
| Measure |
100 mg CTX-4430
n=59 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=59 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=118 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=57 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Change From Baseline at 48 Weeks for Forced Vital Capacity Percent Predicted (FVC) and FEF25-75% (Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity) Percent Predicted
Forced vital capacity (FVC) percent predicted
|
-1.57 absolute change of percent predicted
Interval -3.37 to 0.23
|
-2.06 absolute change of percent predicted
Interval -3.88 to -0.25
|
-1.82 absolute change of percent predicted
Interval -3.1 to -0.54
|
-1.41 absolute change of percent predicted
Interval -3.32 to 0.51
|
|
Change From Baseline at 48 Weeks for Forced Vital Capacity Percent Predicted (FVC) and FEF25-75% (Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity) Percent Predicted
Forced expiratory flow(FEF25-75%)percent predicted
|
-1.61 absolute change of percent predicted
Interval -4.26 to 1.03
|
-4.79 absolute change of percent predicted
Interval -7.46 to -2.11
|
-3.20 absolute change of percent predicted
Interval -5.08 to -1.32
|
-4.38 absolute change of percent predicted
Interval -7.2 to -1.57
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Change From Baseline for Specified Biomarkers
Sputum DNA
|
0.06 log10(mcg/mL)
Interval -0.13 to 0.25
|
0.17 log10(mcg/mL)
Interval 0.01 to 0.34
|
0.12 log10(mcg/mL)
Interval -0.01 to 0.24
|
-0.05 log10(mcg/mL)
Interval -0.22 to 0.12
|
|
Change From Baseline for Specified Biomarkers
Sputum Elastase
|
-0.02 log10(mcg/mL)
Interval -0.2 to 0.16
|
0.17 log10(mcg/mL)
Interval 0.02 to 0.33
|
0.08 log10(mcg/mL)
Interval -0.04 to 0.2
|
-0.08 log10(mcg/mL)
Interval -0.25 to 0.08
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.
Outcome measures
| Measure |
100 mg CTX-4430
n=51 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=55 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=106 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=51 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Change From Baseline for C-reactive Protein (Hs-CRP)
|
2.16 mg/dL
Interval -1.84 to 6.16
|
-0.33 mg/dL
Interval -4.21 to 3.56
|
0.92 mg/dL
Interval -1.87 to 3.7
|
-1.87 mg/dL
Interval -5.91 to 2.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plans states the two active doses will be compared to placebo individually as well as combined. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Outcome measures
| Measure |
100 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=25 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=47 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=24 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline
|
0.84 pulmonary exacerbations per year
Interval 0.49 to 1.44
|
1.28 pulmonary exacerbations per year
Interval 0.84 to 1.96
|
1.04 pulmonary exacerbations per year
Interval 0.74 to 1.46
|
1.61 pulmonary exacerbations per year
Interval 1.07 to 2.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plan states the two active doses will be compared to placebo individually as well as pooled.
Hazard ratio of pulmonary exacerbation versus placebo for all subjects
Outcome measures
| Measure |
100 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=25 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=47 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline
|
0.52 hazard ratio
Interval 0.245 to 1.101
|
0.62 hazard ratio
Interval 0.304 to 1.274
|
0.57 hazard ratio
Interval 0.307 to 1.051
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects with Baseline ppFEV1 \>75.
Subjects who did not experience a protocol-defined pulmonary exacerbation during the study.
Outcome measures
| Measure |
100 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=25 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=47 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=24 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Subjects Without a Pulmonary Exacerbation by Participants With ppFEV1 >75 at Baseline
|
11 Participants
|
12 Participants
|
23 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Outcome measures
| Measure |
100 mg CTX-4430
n=21 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=43 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=19 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Number of Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline
|
1.24 pulmonary exacerbations per year
Interval 0.78 to 1.96
|
1.08 pulmonary exacerbations per year
Interval 0.67 to 1.74
|
1.16 pulmonary exacerbations per year
Interval 0.83 to 1.61
|
1.45 pulmonary exacerbations per year
Interval 0.91 to 2.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.
Hazard Ratio pulmonary exacerbation versus placebo for all subjects taking CFTR-modulating therapy at Baseline
Outcome measures
| Measure |
100 mg CTX-4430
n=21 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=43 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Hazard Ratio Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline
|
0.73 hazard ratio
Interval 0.328 to 1.641
|
0.69 hazard ratio
Interval 0.313 to 1.514
|
0.71 hazard ratio
Interval 0.359 to 1.408
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Population: Population of subjects taking CFTR modulating therapy at Baseline.
Subjects who did not experience a protocol-defined pulmonary exacerbation during the study.
Outcome measures
| Measure |
100 mg CTX-4430
n=21 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=22 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=43 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=19 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Subjects Without a Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline
|
10 Participants
|
10 Participants
|
20 Participants
|
6 Participants
|
POST_HOC outcome
Timeframe: Week 48Population: Subject's FEV1 percent predicted at screening are presented below.
Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.
Outcome measures
| Measure |
100 mg CTX-4430
n=66 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 Participants
Once daily oral capsule for 48 weeks
CTX-4430
|
Pooled CTX-4430
n=133 Participants
The average of the Week 48 absolute change from Baseline in FEV1 percent predicted for the two CTX-4430 doses.
|
Matching Placebo
n=66 Participants
Once daily oral capsule for 48 weeks
|
|---|---|---|---|---|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>70%
|
0.9198 pulmonary exacerbations per year
Interval 0.593 to 1.4269
|
1.1995 pulmonary exacerbations per year
Interval 0.825 to 1.744
|
1.0504 pulmonary exacerbations per year
Interval 0.7871 to 1.4018
|
1.5365 pulmonary exacerbations per year
Interval 1.0912 to 2.1636
|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>50%
|
1.5094 pulmonary exacerbations per year
Interval 1.1549 to 1.9727
|
1.4376 pulmonary exacerbations per year
Interval 1.0991 to 1.8803
|
1.4731 pulmonary exacerbations per year
Interval 1.2187 to 1.7806
|
1.5297 pulmonary exacerbations per year
Interval 1.1708 to 1.9986
|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>55%
|
1.5006 pulmonary exacerbations per year
Interval 1.1265 to 1.9989
|
1.4159 pulmonary exacerbations per year
Interval 1.076 to 1.8633
|
1.4576 pulmonary exacerbations per year
Interval 1.1952 to 1.7777
|
1.5425 pulmonary exacerbations per year
Interval 1.1643 to 2.0435
|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>60%
|
1.2698 pulmonary exacerbations per year
Interval 0.9181 to 1.7561
|
1.4446 pulmonary exacerbations per year
Interval 1.0907 to 1.9133
|
1.3544 pulmonary exacerbations per year
Interval 1.0928 to 1.6785
|
1.4728 pulmonary exacerbations per year
Interval 1.0795 to 2.0094
|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>65%
|
1.0473 pulmonary exacerbations per year
Interval 0.717 to 1.5298
|
1.2523 pulmonary exacerbations per year
Interval 0.9018 to 1.739
|
1.1452 pulmonary exacerbations per year
Interval 0.8912 to 1.4716
|
1.4489 pulmonary exacerbations per year
Interval 1.054 to 1.9918
|
|
Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48
Baseline FEV1>75%
|
0.8417 pulmonary exacerbations per year
Interval 0.4913 to 1.4418
|
1.2786 pulmonary exacerbations per year
Interval 0.8358 to 1.956
|
1.0374 pulmonary exacerbations per year
Interval 0.7361 to 1.4619
|
1.6125 pulmonary exacerbations per year
Interval 1.0728 to 2.4237
|
Adverse Events
100 mg CTX-4430
Serious events: 27 serious events
Other events: 66 other events
Deaths: 0 deaths
50 mg CTX-4430
Serious events: 26 serious events
Other events: 67 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 21 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 mg CTX-4430
n=66 participants at risk
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 participants at risk
Once daily oral capsule for 48 weeks
CTX-4430
|
Matching Placebo
n=66 participants at risk
Once daily oral capsule for 48 weeks
Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Appendicitis
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
31.8%
21/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
34.3%
23/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
28.8%
19/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Scedosporium infection
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline serous tumour of ovary
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Surgical and medical procedures
Antibiotic therapy
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Surgical and medical procedures
Therapeutic embolisation
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Surgical and medical procedures
Therapy Change
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
Other adverse events
| Measure |
100 mg CTX-4430
n=66 participants at risk
Once daily oral capsule for 48 weeks
CTX-4430
|
50 mg CTX-4430
n=67 participants at risk
Once daily oral capsule for 48 weeks
CTX-4430
|
Matching Placebo
n=66 participants at risk
Once daily oral capsule for 48 weeks
Placebo
|
|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
65.2%
43/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
67.2%
45/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
74.2%
49/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
29/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
40.3%
27/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
31.8%
21/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
18.2%
12/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
25.4%
17/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
16.7%
11/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
21.2%
14/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
16.4%
11/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
19.7%
13/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Nervous system disorders
Headache
|
13.6%
9/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
23.9%
16/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.6%
7/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
10.6%
7/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
19.4%
13/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
16.7%
11/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
General disorders
Fatigue
|
13.6%
9/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
13.4%
9/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.6%
7/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.6%
9/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.4%
7/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.1%
8/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.4%
7/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
13.6%
9/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
General disorders
Pyrexia
|
12.1%
8/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
9.0%
6/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.6%
7/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
13.4%
9/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
8/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.5%
5/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
General disorders
Chest discomfort
|
12.1%
8/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.6%
7/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
3/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
10.4%
7/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Sinusitis
|
9.1%
6/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Influenza
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Rhinitis
|
4.5%
3/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
0.00%
0/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Investigations
Forced expiratory volume decreased
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Investigations
Sputum Abnormal
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Investigations
Weight decreased
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
9.0%
6/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
3/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
6.0%
4/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.5%
5/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
6.1%
4/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
9.0%
6/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.0%
2/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.5%
5/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
7.6%
5/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
6/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
4.5%
3/67 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
|
1.5%
1/66 • Baseline up to 28 days after the subject's last dose of study medication where the last dose is 48 weeks or early discontinuation of study drug.
An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with this product. For purposes of this trial, AEs will be reported from the signing of the study informed consent (ICF) through study completion or early termination. A Treatment-Emergent AE is an AE that occurs after the first dose of study medication.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication or (2) 24 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 90 days (which may be extended under certain circumstances related to protection of intellectual property as well as for deletion of any Confidential Information).
- Publication restrictions are in place
Restriction type: OTHER