Trial Outcomes & Findings for Safety Study of Ivacaftor in Subjects With Cystic Fibrosis (NCT NCT00457821)
NCT ID: NCT00457821
Last Updated: 2012-10-05
Results Overview
Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline to Follow-up
Results posted on
2012-10-05
Participant Flow
Part 1 started on 10 May 2007 (signing of first informed consent). After obtaining consent, Part 1 screening evaluations were completed during Day -28 to Day -2. Part 2 started on 28 May 2008 (signing of first informed consent). Part 2 screening evaluations were also completed during Day -28 to Day -2 before the first dose of study drug.
In Part 1, 21 subjects were randomized but 1 subject was excluded prior to dosing because the subject needed a protocol-prohibited medication. In Part 2, 20 subjects were randomized but 1 subject withdrew consent to the study prior to dosing.
Participant milestones
| Measure |
Part 1: Placebo
Part 1: placebo every 12 hours (q12h); 14 days/14 days.
|
Part 1: 25 mg/75 mg
Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/25 mg
Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/150 mg
Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 150 mg/75 mg
Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 2: 150 mg
Part 2: Ivacaftor (150 mg) q12h; 28 days
|
Part 2: 250 mg
Part 2: Ivacaftor (250 mg) q12h; 28 days
|
Part 2: Placebo
Part 2: placebo q12h; 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
4
|
4
|
5
|
4
|
4
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
8
|
7
|
5
|
|
Part 2
Completed Study Drug Treatment
|
0
|
0
|
0
|
0
|
0
|
8
|
7
|
4
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
7
|
4
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
Part 1: placebo every 12 hours (q12h); 14 days/14 days.
|
Part 1: 25 mg/75 mg
Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/25 mg
Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/150 mg
Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 150 mg/75 mg
Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 2: 150 mg
Part 2: Ivacaftor (150 mg) q12h; 28 days
|
Part 2: 250 mg
Part 2: Ivacaftor (250 mg) q12h; 28 days
|
Part 2: Placebo
Part 2: placebo q12h; 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=4 Participants
Part 1: placebo every 12 hours (q12h); 14 days/14 days.
|
Part 1: 25 mg/75 mg
n=4 Participants
Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/25 mg
n=4 Participants
Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 75 mg/150 mg
n=4 Participants
Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 1: 150 mg/75 mg
n=4 Participants
Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
|
Part 2: 150 mg
n=8 Participants
Part 2: Ivacaftor (150 mg) q12h; 28 days
|
Part 2: 250 mg
n=7 Participants
Part 2: Ivacaftor (250 mg) q12h; 28 days
|
Part 2: Placebo
n=4 Participants
Part 2: placebo q12h; 28 days
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
34.5 years
STANDARD_DEVIATION 14.66 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 12.50 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 7.85 • n=4 Participants
|
23.5 years
STANDARD_DEVIATION 6.45 • n=21 Participants
|
25.6 years
STANDARD_DEVIATION 7.98 • n=8 Participants
|
26.0 years
STANDARD_DEVIATION 7.07 • n=8 Participants
|
26.8 years
STANDARD_DEVIATION 10.69 • n=24 Participants
|
28.7 years
STANDARD_DEVIATION 10.03 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
8 participants
n=8 Participants
|
7 participants
n=8 Participants
|
4 participants
n=24 Participants
|
39 participants
n=42 Participants
|
|
Weight
|
70.05 kilograms
STANDARD_DEVIATION 16.507 • n=5 Participants
|
66.05 kilograms
STANDARD_DEVIATION 12.628 • n=7 Participants
|
73.43 kilograms
STANDARD_DEVIATION 14.366 • n=5 Participants
|
57.48 kilograms
STANDARD_DEVIATION 8.663 • n=4 Participants
|
59.35 kilograms
STANDARD_DEVIATION 18.401 • n=21 Participants
|
61.19 kilograms
STANDARD_DEVIATION 9.857 • n=8 Participants
|
64.46 kilograms
STANDARD_DEVIATION 13.027 • n=8 Participants
|
63.50 kilograms
STANDARD_DEVIATION 7.391 • n=24 Participants
|
64.1 kilograms
STANDARD_DEVIATION 12.42 • n=42 Participants
|
|
Body Mass Index
|
24.195 kilograms per square meter
STANDARD_DEVIATION 3.2002 • n=5 Participants
|
22.455 kilograms per square meter
STANDARD_DEVIATION 2.3133 • n=7 Participants
|
23.653 kilograms per square meter
STANDARD_DEVIATION 3.6216 • n=5 Participants
|
20.960 kilograms per square meter
STANDARD_DEVIATION 2.2522 • n=4 Participants
|
20.788 kilograms per square meter
STANDARD_DEVIATION 4.1527 • n=21 Participants
|
21.896 kilograms per square meter
STANDARD_DEVIATION 0.9770 • n=8 Participants
|
22.703 kilograms per square meter
STANDARD_DEVIATION 1.3980 • n=8 Participants
|
22.035 kilograms per square meter
STANDARD_DEVIATION 0.6999 • n=24 Participants
|
22.3 kilograms per square meter
STANDARD_DEVIATION 2.37 • n=42 Participants
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
|
64.902 percentage of volume in liters
STANDARD_DEVIATION 22.6821 • n=5 Participants
|
71.073 percentage of volume in liters
STANDARD_DEVIATION 27.2307 • n=7 Participants
|
54.885 percentage of volume in liters
STANDARD_DEVIATION 9.6772 • n=5 Participants
|
68.284 percentage of volume in liters
STANDARD_DEVIATION 24.7014 • n=4 Participants
|
49.270 percentage of volume in liters
STANDARD_DEVIATION 7.5615 • n=21 Participants
|
70.443 percentage of volume in liters
STANDARD_DEVIATION 25.4442 • n=8 Participants
|
72.674 percentage of volume in liters
STANDARD_DEVIATION 21.5223 • n=8 Participants
|
79.351 percentage of volume in liters
STANDARD_DEVIATION 28.7018 • n=24 Participants
|
67.3 percentage of volume in liters
STANDARD_DEVIATION 22.17 • n=42 Participants
|
|
Genotype
G551D/1078 DEL T
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/DELTA F508
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
7 participants
n=8 Participants
|
5 participants
n=8 Participants
|
4 participants
n=24 Participants
|
32 participants
n=42 Participants
|
|
Genotype
G551D/G551D
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/N1303K
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/R553X
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/3849 AND 10KBC
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/6214 + 1G > 7T
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Genotype
G551D/G542X
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to Follow-upPopulation: All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).
Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.
Outcome measures
| Measure |
Placebo
n=8 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=31 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (Combined Part 1 and Part 2)
Subjects with AEs
|
7 participants
|
26 participants
|
—
|
—
|
—
|
|
Number of Subjects With Adverse Events (Combined Part 1 and Part 2)
Subjects with Related or Possibly Related AEs
|
3 participants
|
13 participants
|
—
|
—
|
—
|
|
Number of Subjects With Adverse Events (Combined Part 1 and Part 2)
Subjects with SAEs
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Subjects With Adverse Events (Combined Part 1 and Part 2)
Subjects with Related or Possibly Related SAEs
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Follow-upPopulation: All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).
Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.
Outcome measures
| Measure |
Placebo
n=8 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=31 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Number of Adverse Events (Combined Part 1 and Part 2)
Number of Adverse Events (AEs)
|
32 events
|
179 events
|
—
|
—
|
—
|
|
Number of Adverse Events (Combined Part 1 and Part 2)
Number of Related or Possibly Related AEs
|
11 events
|
40 events
|
—
|
—
|
—
|
|
Number of Adverse Events (Combined Part 1 and Part 2)
Number of Serious Adverse Events (SAEs)
|
0 events
|
2 events
|
—
|
—
|
—
|
|
Number of Adverse Events (Combined Part 1 and Part 2)
Number of Related or Possibly Related SAEs
|
0 events
|
0 events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days and 28 daysPopulation: Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.
The transepithelial nasal potential difference (NPD) is a direct measure of transepithelial ion transport. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol was of primary interest.
Outcome measures
| Measure |
Placebo
n=12 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=7 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
n=15 Participants
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
n=16 Participants
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
n=7 Participants
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)
Amiloride, Day ≥ 14
|
-0.7 millivolts
Interval -5.5 to 4.1
|
-0.3 millivolts
Interval -6.8 to 6.2
|
-3.7 millivolts
Interval -8.4 to -1.0
|
-8.8 millivolts
Interval -12.8 to -4.8
|
-4.0 millivolts
Interval -9.2 to 1.2
|
|
Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)
Zero Chloride + Isoproterenol, Day 14
|
-0.3 millivolts
Interval -3.5 to 2.9
|
-1.4 millivolts
Interval -5.2 to 2.4
|
-4.4 millivolts
Interval -7.0 to -1.8
|
-4.6 millivolts
Interval -7.2 to -2.0
|
-7.6 millivolts
Interval -11.7 to -3.5
|
|
Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)
Zero Chloride + Isoproterenol, Day ≥ 14
|
-0.5 millivolts
Interval -4.1 to 3.1
|
-1.3 millivolts
Interval -5.2 to 2.6
|
-4.5 millivolts
Interval -7.3 to -1.7
|
-5.3 millivolts
Interval -7.9 to -2.6
|
-8.4 millivolts
Interval -12.3 to -4.5
|
|
Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)
Amiloride, Day 14
|
0.3 millivolts
Interval -5.2 to 5.9
|
-0.1 millivolts
Interval -6.1 to 5.8
|
-4.2 millivolts
Interval -8.3 to 0.0
|
-9.9 millivolts
Interval -14.2 to -5.6
|
-5.5 millivolts
Interval -12.2 to 1.1
|
SECONDARY outcome
Timeframe: 14 days and 28 daysPopulation: Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.
Spirometry is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. Relative change reflects the percent change from the baseline values \[100% \* (X-Y)/Y\], where X and Y are post-baseline and baseline values, respectively.
Outcome measures
| Measure |
Placebo
n=10 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=7 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
n=15 Participants
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
n=16 Participants
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
n=7 Participants
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)
Absolute Change from Baseline, Day 14
|
0.5 percent predicted (%)
Interval -3.4 to 4.5
|
2.7 percent predicted (%)
Interval -1.8 to 7.1
|
5.1 percent predicted (%)
Interval 2.0 to 8.3
|
6.9 percent predicted (%)
Interval 3.9 to 10.0
|
8.4 percent predicted (%)
Interval 3.7 to 13.2
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)
Absolute Change from Baseline, Day ≥ 14
|
2.1 percent predicted (%)
Interval -1.3 to 5.6
|
2.5 percent predicted (%)
Interval -1.3 to 6.2
|
5.3 percent predicted (%)
Interval 2.4 to 8.1
|
6.9 percent predicted (%)
Interval 4.4 to 9.5
|
6.7 percent predicted (%)
Interval 3.1 to 10.3
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)
Relative Change from Baseline, Day 14
|
2.0 percent predicted (%)
Interval -4.8 to 8.9
|
4.7 percent predicted (%)
Interval -2.7 to 12.2
|
9.5 percent predicted (%)
Interval 4.1 to 14.8
|
10.8 percent predicted (%)
Interval 5.6 to 15.9
|
12.0 percent predicted (%)
Interval 3.8 to 20.1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)
Relative Change from Baseline, Day ≥ 14
|
3.3 percent predicted (%)
Interval -2.4 to 9.1
|
4.1 percent predicted (%)
Interval -1.9 to 10.1
|
9.3 percent predicted (%)
Interval 4.7 to 13.9
|
10.6 percent predicted (%)
Interval 6.5 to 14.8
|
9.4 percent predicted (%)
Interval 3.4 to 15.4
|
SECONDARY outcome
Timeframe: 14 days and 28 daysPopulation: Part 2 is a parallel study. Subjects were counted only once for each treatment group.
The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).
Outcome measures
| Measure |
Placebo
n=4 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=8 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
n=7 Participants
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)
Change from Baseline in Respiratory Score, Day 14
|
2.8 score on a scale
Standard Deviation 7.2
|
6.3 score on a scale
Standard Deviation 6.9
|
5.6 score on a scale
Standard Deviation 7.9
|
—
|
—
|
|
Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)
Baseline Respiratory Domain Score
|
70.8 score on a scale
Standard Deviation 21.5
|
68.8 score on a scale
Standard Deviation 23.9
|
73.0 score on a scale
Standard Deviation 8.7
|
—
|
—
|
|
Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)
Change from Baseline in Respiratory Score, Day 28
|
2.8 score on a scale
Standard Deviation 7.2
|
6.9 score on a scale
Standard Deviation 6.5
|
11.9 score on a scale
Standard Deviation 14.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days and 28 daysPopulation: Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.
The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.
Outcome measures
| Measure |
Placebo
n=12 Participants
All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
|
Ivacaftor
n=8 Participants
All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
|
75 mg Ivacaftor q12h
n=14 Participants
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
n=16 Participants
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
n=7 Participants
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)
Change from Baseline in Sweat Chloride, Day 14
|
2.0 millimoles per liter
Interval -9.1 to 13.1
|
-33.8 millimoles per liter
Interval -43.4 to -24.2
|
-42.0 millimoles per liter
Interval -49.9 to -34.1
|
-46.0 millimoles per liter
Interval -53.9 to -38.2
|
-27.1 millimoles per liter
Interval -39.7 to -14.6
|
|
Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)
Change from Baseline in Sweat Chloride, Day ≥14
|
4.9 millimoles per liter
Interval -5.3 to 15.0
|
-32.9 millimoles per liter
Interval -41.7 to -24.2
|
-40.8 millimoles per liter
Interval -48.1 to -33.5
|
-44.2 millimoles per liter
Interval -51.1 to -37.3
|
-28.2 millimoles per liter
Interval -39.0 to -17.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
25 mg Ivacaftor q12h
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
75 mg Ivacaftor q12h
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
150 mg Ivacaftor q12h
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
250 mg Ivacaftor q12h
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
|
25 mg Ivacaftor q12h
n=8 participants at risk
All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
|
75 mg Ivacaftor q12h
n=16 participants at risk
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
n=16 participants at risk
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
n=7 participants at risk
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
|
25 mg Ivacaftor q12h
n=8 participants at risk
All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
|
75 mg Ivacaftor q12h
n=16 participants at risk
All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
|
150 mg Ivacaftor q12h
n=16 participants at risk
All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
|
250 mg Ivacaftor q12h
n=7 participants at risk
All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • Number of events 4 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
42.9%
3/7 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough decreased
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate abnormality
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum decreased
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
25.0%
4/16 • Number of events 5 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 4 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Catheter related complication
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Chills
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Infusion site reaction
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Pain
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Injection site oedema
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
General disorders
Mucosal erosion
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Chronic sinusitis
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Blood glucose increased
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Glucose urine present
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Breath sounds abnormal
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Sputum abnormal
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
White blood cells urine positive
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Investigations
Cardiac murmur
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Vascular disorders
Haematoma
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
14.3%
1/7 • Number of events 2 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
|
Reproductive system and breast disorders
Genital pruritus female
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/8 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/16 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
0.00%
0/7 • Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60