Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency (NCT NCT00297167)
NCT ID: NCT00297167
Last Updated: 2017-03-16
Results Overview
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods
Results posted on
2017-03-16
Participant Flow
Out of 34 participants who were enrolled and treated during open-label dose titration and stabilization period, 1 participant withdrew from the study before randomization to first double-blind intervention period.
Participant milestones
| Measure |
Placebo First, Then EUR-1008 (APT-1008)
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
|
EUR-1008 (APT-1008) First, Then Placebo
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
EUR-1008 (APT-1008) (Open-label)
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
|
|---|---|---|---|
|
First Double-blind Intervention Period
STARTED
|
17
|
16
|
0
|
|
First Double-blind Intervention Period
COMPLETED
|
17
|
16
|
0
|
|
First Double-blind Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Open-label Dose Normalization Period 1
STARTED
|
0
|
0
|
33
|
|
Open-label Dose Normalization Period 1
COMPLETED
|
0
|
0
|
32
|
|
Open-label Dose Normalization Period 1
NOT COMPLETED
|
0
|
0
|
1
|
|
Second Double-blind Intervention Period
STARTED
|
17
|
15
|
0
|
|
Second Double-blind Intervention Period
COMPLETED
|
16
|
15
|
0
|
|
Second Double-blind Intervention Period
NOT COMPLETED
|
1
|
0
|
0
|
|
Open-label Dose Normalization Period 2
STARTED
|
0
|
0
|
31
|
|
Open-label Dose Normalization Period 2
COMPLETED
|
0
|
0
|
31
|
|
Open-label Dose Normalization Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo First, Then EUR-1008 (APT-1008)
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
|
EUR-1008 (APT-1008) First, Then Placebo
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
EUR-1008 (APT-1008) (Open-label)
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
|
|---|---|---|---|
|
Open-label Dose Normalization Period 1
Withdrawal by Subject
|
0
|
0
|
1
|
|
Second Double-blind Intervention Period
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=34 Participants
Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
|
|---|---|
|
Age, Continuous
|
14.9 years
STANDARD_DEVIATION 4.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=31 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Percent Coefficient of Fat Absorption (CFA%)
|
88.28 percent CFA
Standard Error 2.599
|
62.76 percent CFA
Standard Error 2.639
|
SECONDARY outcome
Timeframe: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Percent CNA was calculated as (\[nitrogen intake-nitrogen excretion\]/nitrogen intake)\*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=31 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Percent Coefficient of Nitrogen Absorption (CNA%)
|
87.17 percent CNA
Standard Error 2.179
|
65.67 percent CNA
Standard Error 2.213
|
SECONDARY outcome
Timeframe: End of treatment (Day 6 during first and second double-blind intervention periods)Population: Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specific time point in each treatment arm.
Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=33 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=30 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Lipid Levels
TC: End of Treatment (n=33, 30)
|
128.8 milligram/deciliter (mg/dL)
Standard Deviation 28.98
|
109.1 milligram/deciliter (mg/dL)
Standard Deviation 29.76
|
|
Lipid Levels
HDL-C: End of Treatment (n=33, 30)
|
45.5 milligram/deciliter (mg/dL)
Standard Deviation 10.85
|
37.2 milligram/deciliter (mg/dL)
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: End of treatment (Day 6 during first and second double-blind intervention periods)Population: Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=33 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=30 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Vitamin A Levels
|
422.3 microgram per liter (mcg/L)
Standard Deviation 111.67
|
363.2 microgram per liter (mcg/L)
Standard Deviation 100.33
|
SECONDARY outcome
Timeframe: End of treatment (Day 6 during first and second double-blind intervention periods)Population: Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=33 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=30 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Vitamin E Levels
|
8.25 mg/L
Standard Deviation 3.115
|
6.69 mg/L
Standard Deviation 2.648
|
SECONDARY outcome
Timeframe: Day 3 up to Day 6 during first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.
Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=32 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Mean Daily Number of Stools
|
1.76 stools per day
Standard Deviation 0.898
|
2.66 stools per day
Standard Deviation 1.418
|
SECONDARY outcome
Timeframe: Day 3 up to Day 6 during first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.
Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=32 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Percentage of Stool Categorized as Per Consistency
Hard
|
16.54 percentage of stools
Standard Deviation 29.637
|
6.24 percentage of stools
Standard Deviation 18.845
|
|
Percentage of Stool Categorized as Per Consistency
Formed/Normal
|
53.86 percentage of stools
Standard Deviation 37.253
|
33.25 percentage of stools
Standard Deviation 34.414
|
|
Percentage of Stool Categorized as Per Consistency
Soft
|
29.24 percentage of stools
Standard Deviation 34.096
|
57.11 percentage of stools
Standard Deviation 36.105
|
|
Percentage of Stool Categorized as Per Consistency
Watery
|
0.36 percentage of stools
Standard Deviation 1.421
|
2.59 percentage of stools
Standard Deviation 4.836
|
|
Percentage of Stool Categorized as Per Consistency
Overt diarrhea
|
0.00 percentage of stools
Standard Deviation 0.000
|
0.82 percentage of stools
Standard Deviation 3.670
|
SECONDARY outcome
Timeframe: Day 3 up to Day 6 during first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.
Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=32 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Mean Number of Abdominal Symptoms
Pain: Moderate
|
0.08 symptoms per day
Standard Deviation 0.379
|
0.32 symptoms per day
Standard Deviation 0.754
|
|
Mean Number of Abdominal Symptoms
Flatulence: Severe
|
0.00 symptoms per day
Standard Deviation 0.000
|
0.18 symptoms per day
Standard Deviation 0.719
|
|
Mean Number of Abdominal Symptoms
Bloating: Mild
|
0.10 symptoms per day
Standard Deviation 0.300
|
0.31 symptoms per day
Standard Deviation 0.718
|
|
Mean Number of Abdominal Symptoms
Bloating: Moderate
|
0.05 symptoms per day
Standard Deviation 0.191
|
0.10 symptoms per day
Standard Deviation 0.329
|
|
Mean Number of Abdominal Symptoms
Bloating: Severe
|
0.00 symptoms per day
Standard Deviation 0.000
|
0.09 symptoms per day
Standard Deviation 0.495
|
|
Mean Number of Abdominal Symptoms
Flatulence: Mild
|
0.40 symptoms per day
Standard Deviation 0.688
|
0.70 symptoms per day
Standard Deviation 1.134
|
|
Mean Number of Abdominal Symptoms
Flatulence: Moderate
|
0.08 symptoms per day
Standard Deviation 0.275
|
0.41 symptoms per day
Standard Deviation 1.160
|
|
Mean Number of Abdominal Symptoms
Pain: Mild
|
0.16 symptoms per day
Standard Deviation 0.433
|
0.62 symptoms per day
Standard Deviation 0.901
|
|
Mean Number of Abdominal Symptoms
Pain: Severe
|
0.00 symptoms per day
Standard Deviation 0.022
|
0.09 symptoms per day
Standard Deviation 0.228
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.
Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=32 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Percentage of Visible Oil or Grease in Stool
|
6.78 percentage of visible oil or grease/day
Standard Deviation 17.354
|
27.97 percentage of visible oil or grease/day
Standard Deviation 33.571
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periodsPopulation: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.
Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=32 Participants
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
|
Placebo
n=32 Participants
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Percentage of Stools With Blood
|
0.17 percentage of stools with blood per day
Standard Deviation 0.174
|
1.13 percentage of stools with blood per day
Standard Deviation 4.647
|
Adverse Events
EUR-1008 (APT-1008)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EUR-1008 (APT-1008)
n=34 participants at risk
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
|
Placebo
n=32 participants at risk
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
Other adverse events
| Measure |
EUR-1008 (APT-1008)
n=34 participants at risk
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
|
Placebo
n=32 participants at risk
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
9.4%
3/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
4/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
18.8%
6/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
9.4%
3/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Abnormal faeces
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
9.4%
3/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
9.4%
3/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
6.2%
2/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
12.5%
4/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
General disorders
Early satiety
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Injury, poisoning and procedural complications
Injury
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Investigations
Weight decreased
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
6.2%
2/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Nervous system disorders
Headache
|
14.7%
5/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
General disorders
Chest pain
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
General disorders
Oedema mucosal
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
General disorders
Pyrexia
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Injury, poisoning and procedural complications
Anal injury
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Reproductive system and breast disorders
Vaginal burning sensation
|
0.00%
0/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Respiratory, thoracic and mediastinal disorders
Crackles lung
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
3.1%
1/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
|
Vascular disorders
Haematoma
|
2.9%
1/34
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
0.00%
0/32
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) 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 or assessed as important medical event.
|
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 may vary in accordance with each agreement that is negotiated with individual investigators. Sponsor will allow publication after 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 defer publication for period of time to allow Sponsor to obtain patent or other intellectual property right protection.
- Publication restrictions are in place
Restriction type: OTHER