Trial Outcomes & Findings for Prevention of Cystic Fibrosis Diabetes (NCT NCT00967798)
NCT ID: NCT00967798
Last Updated: 2018-06-25
Results Overview
The number of participants with conversion to cystic fibrosis related diabetes was determined.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Month 15
Results posted on
2018-06-25
Participant Flow
Participants were recruited between May 2010 and August 2016.
Participant milestones
| Measure |
Sitagliptin
Participants randomized to receive Sitagliptin
|
Placebo
Participants randomized to receive a placebo
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Sitagliptin
Participants randomized to receive Sitagliptin
|
Placebo
Participants randomized to receive a placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Prevention of Cystic Fibrosis Diabetes
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=17 Participants
Participants randomized to receive Sitagliptin
|
Placebo
n=16 Participants
Participants randomized to receive a placebo
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 15The number of participants with conversion to cystic fibrosis related diabetes was determined.
Outcome measures
| Measure |
Sitagliptin
n=17 Participants
Participants randomized to receive Sitagliptin
|
Placebo
n=16 Participants
Participants randomized to receive a placebo
|
|---|---|---|
|
Number of Participants With Conversion to Cystic Fibrosis Related Diabetes
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 15Population: Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.
Preservation of beta-cell function was to be assessed with the disposition index, which is a measurement of beta-cell function adjusted for insensitivity to insulin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 12Population: Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.
Cysteine (Cys)/cystine (CySS) and glutathione (GSH)/glutathione disulfide (GSSG) redox couples are biomarkers of oxidative stress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 12Population: Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.
Hyperglycemia causes release of pro-inflammatory cytokines which can further compromise beta-cell function by increasing insulin resistance and by inducing beta-cell apoptosis. Inflammatory cytokines that have been shown to contribute to destruction of beta-cells include interleukin 1 beta (IL-1b), tumor necrosis factor alpha (TNFa), and interleukin 6 (IL-6).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, end of treatment (Month 12 or Month 24)Population: The participants included in this analysis are limited to those who have a FEV value for the baseline and end of treatment visits.
The decline of lung function was assessed with forced expiratory volume (FEV1), which measures how much air is exhaled during one second of a forced exhale. Change is described as the difference in FEV1 at baseline subtracted from FEV1 at the end of treatment study visit. A protocol change during the study reduced the treatment time from 24 months to 12 months. The end of treatment study visit for participants in the early part of the study occurred at 24 months, while the end of treatment visit was a 12 months for participants enrolling later. Negative values indicate a decline in lung function over the course of the study.
Outcome measures
| Measure |
Sitagliptin
n=8 Participants
Participants randomized to receive Sitagliptin
|
Placebo
n=13 Participants
Participants randomized to receive a placebo
|
|---|---|---|
|
Change in Percent Predicted FEV1
|
-9.7 percent predicted
Standard Deviation 29.4
|
-8.5 percent predicted
Standard Deviation 14.3
|
Adverse Events
Sitagliptin
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=17 participants at risk
Participants randomized to receive Sitagliptin
|
Placebo
n=16 participants at risk
Participants randomized to receive a placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to Respiratory Event
|
64.7%
11/17 • Number of events 30 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
56.2%
9/16 • Number of events 27 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Skin and subcutaneous tissue disorders
Hospitalization due to erythematous maculopapualr rash
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Lithotripsy with stent placement
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Hospitalization due to osteochondroplasty of femoral neck due to previous motor vehical accident
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Hospitalization due to fever and body aches
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
Other adverse events
| Measure |
Sitagliptin
n=17 participants at risk
Participants randomized to receive Sitagliptin
|
Placebo
n=16 participants at risk
Participants randomized to receive a placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event
|
94.1%
16/17 • Number of events 63 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
100.0%
16/16 • Number of events 109 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Abdominal pain
|
11.8%
2/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
12.5%
2/16 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Abnormal lab results
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Ankle injury
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Infections and infestations
Athletes foot
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Broken/fractured hand bones
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Surgical and medical procedures
Complications with PICC line
|
17.6%
3/17 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Surgical and medical procedures
Complications with port
|
5.9%
1/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Decreased appetite
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
18.8%
3/16 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Difficulty sleeping
|
5.9%
1/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Infections and infestations
Ehrlichiosis
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Elevated bilirubin
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Elevated CO2
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Elevated creatinine
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
12.5%
2/16 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Elevated potassium
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Elevated eosinophils
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Elevated lipid panel/triglycerides
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Elevated prothrombin induced by vitamin K absence-II (PIVKA-II)
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Fatigue
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
12.5%
2/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
12.5%
2/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Head tingling
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Reproductive system and breast disorders
hydroceles with scrotal pain
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Increased thirst and urination
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Intestinal blockage
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Stomach blockage with abdominal pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness in hands
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Renal and urinary disorders
Kidney stones with colic
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Migraine headache
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Nausea/vomiting
|
11.8%
2/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Neck pain from pulled muscle
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Open wound to left forearm
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Reproductive system and breast disorders
Prostratitis with hematuria
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Right knee contusion with edema
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Skin and subcutaneous tissue disorders
Sebaceous cyst, carbuncle on back
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Skin and subcutaneous tissue disorders
Skin irritation from colistin
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
sleeplessness, restlessness, bruising, and muscle tightness
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Musculoskeletal and connective tissue disorders
Tendinitis due to levaquin
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Tongue numbness due to colistin
|
5.9%
1/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Infections and infestations
Tooth abcess
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
6.2%
1/16 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Gastrointestinal disorders
Vomiting and diarrhea
|
11.8%
2/17 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
0.00%
0/16 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
General disorders
Weight loss
|
5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
18.8%
3/16 • Number of events 3 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Surgical and medical procedures
Wisdom teeth extraction
|
0.00%
0/17 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
12.5%
2/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
|
|
Infections and infestations
Yeast infection
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5.9%
1/17 • Number of events 1 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
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12.5%
2/16 • Number of events 2 • For this study, the reporting period for adverse events is from the time the subject signs the informed consent form to 90 days after taking the last dose of the study medication, up to 15 months.
Over 90% of the morbidity in cystic fibrosis (CF) is due to respiratory dysfunction and to readily identify an increase in the frequency of respiratory exacerbations, adverse events will be classified as respiratory or non-respiratory events. Respiratory events are defined as any increase in respiratory symptoms and/or signs (increase sputum production, increase in cough, runny or stuffy nose, a cold, decrease in lung function, and/or change in physical findings of the respiratory system).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place