Trial Outcomes & Findings for Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation (NCT NCT01262352)
NCT ID: NCT01262352
Last Updated: 2013-02-11
Results Overview
Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity \[FRC\]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline through Day 29
Results posted on
2013-02-11
Participant Flow
The study started on 14 February 2011 (signing of first informed consent). After obtaining informed consent and assent (where applicable), screening evaluations were completed at any time during the period 10 to 18 days (Days -18 to -10) before first dose of study drug (Day 1).
A total of 21 subjects were randomized; 20 subjects received at least 1 dose of the study drug.
Participant milestones
| Measure |
Ivacaftor Then Placebo
Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
|
Placebo Then Ivacaftor
Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
11
|
10
|
|
Period 1
Dosed
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
10
|
10
|
|
Washout
COMPLETED
|
9
|
8
|
|
Washout
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
9
|
8
|
|
Period 2
Dosed
|
9
|
8
|
|
Period 2
COMPLETED
|
9
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ivacaftor Then Placebo
Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
|
Placebo Then Ivacaftor
Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
|
|---|---|---|
|
Period 1
Illness after randomization
|
1
|
0
|
|
Washout
Adverse Event
|
1
|
1
|
|
Washout
Extended Washout
|
0
|
1
|
Baseline Characteristics
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
Baseline characteristics by cohort
| Measure |
Ivacaftor Then Placebo
n=10 Participants
Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
|
Placebo Then Ivacaftor
n=10 Participants
Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
13.4 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 13.35 • n=7 Participants
|
16.6 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Height
|
148.9 centimeters
STANDARD_DEVIATION 19.54 • n=5 Participants
|
156.0 centimeters
STANDARD_DEVIATION 17.92 • n=7 Participants
|
152.5 centimeters
STANDARD_DEVIATION 18.61 • n=5 Participants
|
|
Weight
|
45.06 kilograms
STANDARD_DEVIATION 20.018 • n=5 Participants
|
58.78 kilograms
STANDARD_DEVIATION 30.576 • n=7 Participants
|
51.92 kilograms
STANDARD_DEVIATION 26.119 • n=5 Participants
|
|
Body Mass Index
|
19.36 kilograms per square meter
STANDARD_DEVIATION 3.707 • n=5 Participants
|
22.66 kilograms per square meter
STANDARD_DEVIATION 6.964 • n=7 Participants
|
21.01 kilograms per square meter
STANDARD_DEVIATION 5.687 • n=5 Participants
|
|
Lung Clearance Index (LCI)
|
9.17 ratio
STANDARD_DEVIATION 1.657 • n=5 Participants
|
8.88 ratio
STANDARD_DEVIATION 1.462 • n=7 Participants
|
9.03 ratio
STANDARD_DEVIATION 1.528 • n=5 Participants
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
|
101.83 percentage
STANDARD_DEVIATION 11.587 • n=5 Participants
|
92.58 percentage
STANDARD_DEVIATION 7.427 • n=7 Participants
|
97.20 percentage
STANDARD_DEVIATION 10.595 • n=5 Participants
|
|
Sweat Chloride
|
97.10 millimoles per liter
STANDARD_DEVIATION 7.400 • n=5 Participants
|
86.17 millimoles per liter
STANDARD_DEVIATION 19.219 • n=7 Participants
|
91.92 millimoles per liter
STANDARD_DEVIATION 14.933 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 29Population: All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.
Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity \[FRC\]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.
Outcome measures
| Measure |
Placebo
n=18 Participants
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=17 Participants
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Absolute Change From Baseline in Lung Clearance Index (LCI)
|
0.77 ratio
Standard Error 0.291
|
-1.30 ratio
Standard Error 0.303
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.
Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.
Outcome measures
| Measure |
Placebo
n=19 Participants
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=18 Participants
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Absolute Change From Baseline in Percent Predicted FEV1
|
0.00 percent
Standard Error 1.916
|
7.00 percent
Standard Error 1.978
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.
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=18 Participants
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=16 Participants
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Change From Baseline in Sweat Chloride
|
0.11 millimoles per liter
Standard Error 2.351
|
-45.74 millimoles per liter
Standard Error 2.632
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.
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). The primary analytical focus was the respiratory health domain, which was analyzed by combining all self-response questionnaire versions from different age groups (e.g., Adult/Adolescent and Child versions).
Outcome measures
| Measure |
Placebo
n=19 Participants
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=18 Participants
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)
|
1.33 score on a scale
Standard Error 3.067
|
5.32 score on a scale
Standard Error 3.166
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Ivacaftor
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=19 participants at risk
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=18 participants at risk
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Distal ileal obstruction syndrome
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Oral tablet every 12 hours (q12h) for up to 28 days.
|
Ivacaftor
n=18 participants at risk
Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • Number of events 4 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
2/19 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.8%
7/19 • Number of events 10 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
27.8%
5/18 • Number of events 5 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.5%
2/19 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.3%
1/19 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
22.2%
4/18 • Number of events 4 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
11.1%
2/18 • Number of events 3 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
General disorders
Pyrexia
|
15.8%
3/19 • Number of events 3 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
General disorders
Application site papules
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.5%
2/19 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Gastrointestinal viral infection
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Mycobacterium abscessus infection
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Oral candidiasis
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Pneumococcal infection
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Staphylococcal infection
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Investigations
Bacteria sputum identified
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Investigations
Bacterial culture positive
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Investigations
Lymph node palpable
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
11.1%
2/18 • Number of events 2 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/19 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
5.6%
1/18 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
5.3%
1/19 • Number of events 1 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
0.00%
0/18 • For enrolled subjects, all adverse events were collected through the Follow-up Visit (4 weeks [+/-7 days] after the last dose of study drug).
For subjects who were screened but were not subsequently enrolled in the study, all adverse events were collected until the subject was deemed ineligible for the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER