Trial Outcomes & Findings for PR-018: An Open-Label, Safety Extension of Study PR-011 (NCT NCT01131507)
NCT ID: NCT01131507
Last Updated: 2017-03-21
Results Overview
TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild \[minimal/no treatment and did not interfere with daily activities\], moderate \[resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning\] and severe \[interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating\]) with a frequency threshold of above 5% were reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Up to Month 12 or early termination
Results posted on
2017-03-21
Participant Flow
Participants who completed previous study PR-011 (NCT01100606) and consented to continue treatment with EUR-1008 (APT-1008) 3,000 lipase units were enrolled in this study.
Participant milestones
| Measure |
EUR-1008 (APT-1008)
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
EUR-1008 (APT-1008)
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
PR-018: An Open-Label, Safety Extension of Study PR-011
Baseline characteristics by cohort
| Measure |
EUR-1008 (APT-1008)
n=15 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Age, Continuous
|
9.0 months
FULL_RANGE 3.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Weight
|
7.80 kilogram
FULL_RANGE 1.296 • n=5 Participants
|
|
Length
|
68.5 centimeter
FULL_RANGE 5.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12 or early terminationPopulation: Safety population included all participants who received at least 1 dose of study drug.
TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild \[minimal/no treatment and did not interfere with daily activities\], moderate \[resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning\] and severe \[interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating\]) with a frequency threshold of above 5% were reported.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=15 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
15 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
SAEs
|
3 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Unrelated TEAEs
|
10 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Possibly related TEAEs
|
4 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Probably related TEAEs
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Mild TEAEs
|
5 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Moderate TEAEs
|
8 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Severe TEAEs
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9 and 12Population: Safety population included all participants who received at least 1 dose of study drug. Here, 'n' specifies number of participants who were evaluable for various categories at each time point.
Participant's ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=15 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-age: Baseline (n=15)
|
22.0 growth percentile
Interval 2.0 to 91.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-age: Change at Month 3 (n=15)
|
2.0 growth percentile
Interval -18.0 to 34.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-age: Change at Month 6 (n=13)
|
6.0 growth percentile
Interval -35.0 to 34.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-age: Change at Month 9 (n=12)
|
4.0 growth percentile
Interval -42.0 to 34.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-age: Change at Month 12 (n=12)
|
5.5 growth percentile
Interval -45.0 to 36.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Length-for-age: Baseline (n=14)
|
36.5 growth percentile
Interval 1.0 to 74.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Length-for-age: Change at Month 3 (n=14)
|
2.0 growth percentile
Interval -22.0 to 30.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Length-for-age: Change at Month 6 (n=12)
|
2.0 growth percentile
Interval -23.0 to 28.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Length-for-age: Change at Month 9 (n=12)
|
11.0 growth percentile
Interval -24.0 to 34.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Length-for-age: Change at Month 12 (n=12)
|
0.5 growth percentile
Interval -27.0 to 53.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-length: Baseline (n=14)
|
41.5 growth percentile
Interval 8.0 to 98.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-length: Change at Month 3 (n=14)
|
0.5 growth percentile
Interval -12.0 to 41.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-length: Change at Month 6 (n=12)
|
13.5 growth percentile
Interval -17.0 to 47.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-length: Change at Month 9 (n=12)
|
9.0 growth percentile
Interval -54.0 to 31.0
|
|
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Weight-for-length: Change at Month 12 (n=12)
|
10.5 growth percentile
Interval -57.0 to 48.0
|
Adverse Events
EUR-1008 (APT-1008)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EUR-1008 (APT-1008)
n=15 participants at risk
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Infections and infestations
Bronchopneumonia
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Viral infection
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Immune system disorders
Anaphylactic shock
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
Other adverse events
| Measure |
EUR-1008 (APT-1008)
n=15 participants at risk
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
80.0%
12/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
73.3%
11/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
53.3%
8/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
46.7%
7/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
26.7%
4/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Steatorrhoea
|
26.7%
4/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abnormal faeces
|
20.0%
3/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal distension
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Faecal volume increased
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Teething
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Faeces hard
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Haematochezia
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Malabsorption
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
6/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Otitis media
|
33.3%
5/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Bronchitis
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Pseudomonas infection
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Rhinitis
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Sinusitis
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Acute sinusitis
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Croup infectious
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Staphylococcal infection
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
General disorders
Pyrexia
|
66.7%
10/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Investigations
Weight decreased
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Investigations
Band neutrophil count increased
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Investigations
Pseudomonas test positive
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
20.0%
3/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
13.3%
2/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Immune system disorders
Drug hypersensitivity
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Eye disorders
Eyelid margin crusting
|
6.7%
1/15 • Up to Month 12 or early termination
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
Additional Information
Robert Winkler, MD, VP, Clinical Development and Operations
Aptalis Pharma US, Inc.
Phone: 1-800-472-2634
Results disclosure agreements
- Principal investigator is a sponsor employee Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
- Publication restrictions are in place
Restriction type: OTHER