Trial Outcomes & Findings for A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis (NCT NCT03924947)
NCT ID: NCT03924947
Last Updated: 2023-09-28
Results Overview
CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Up to Day 8 of each DB treatment period
Results posted on
2023-09-28
Participant Flow
This study was conducted in 2 independent parts, and gave participants the option to participate in both. The screening period for each Part included an Open Label (OL) Pre-Randomization Period during which participants were expected to receive OL study drug while they were evaluated for eligibility. Therefore, some participants received treatment in the study who were not enrolled per the protocol definition of enrollment (i.e. randomized).
A total of 36 unique participants enrolled in the study, with 13 participants enrolling in both parts. Participants who decided to participate in Parts 1 or 2 within ≤ 30 days since completion of the other Part did not need to repeat all screening procedures for the second study Part (including the OL Pre-Randomization Period) before beginning in that Part's Double-Blind (DB) Treatment Period.
Participant milestones
| Measure |
Part 1 OL Creon
OL currently marketed Creon delayed release (DR) capsules for up to 35 days during a pre-randomization period.
|
Part 1 DB Creon MP / Creon
Participants received DB Creon DR capsules manufactured by modernized process (Creon MP) in treatment period 1, followed by DB currently marketed Creon DR capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 1 DB Creon / Creon MP
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon MP in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 OL Creon
OL currently marketed Creon DR capsules for up to 35 days during a pre-randomization period.
|
Part 2 DB Creon AAPIS / Creon
Participants received DB Creon DR capsules manufactured at an alternate active pharmaceutical ingredient site (Creon AAPIS) in treatment period 1, followed by DB currently marketed Creon DR Capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 DB Creon / Creon AAPIS
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon AAPIS in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Open Label Pre-Randomization
STARTED
|
26
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open Label Pre-Randomization
COMPLETED
|
26
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Open Label Pre-Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 1
STARTED
|
0
|
13
|
13
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 1
COMPLETED
|
0
|
13
|
12
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 2
STARTED
|
0
|
13
|
12
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 2
COMPLETED
|
0
|
13
|
12
|
0
|
0
|
0
|
|
Part 1: Double Blind Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Open Label Pre-Randomization
STARTED
|
0
|
0
|
0
|
24
|
0
|
0
|
|
Part 2: Open Label Pre-Randomization
COMPLETED
|
0
|
0
|
0
|
24
|
0
|
0
|
|
Part 2: Open Label Pre-Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Double Blind Period 1
STARTED
|
0
|
0
|
0
|
0
|
11
|
12
|
|
Part 2: Double Blind Period 1
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
12
|
|
Part 2: Double Blind Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Double Blind Period 2
STARTED
|
0
|
0
|
0
|
0
|
11
|
12
|
|
Part 2: Double Blind Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
11
|
|
Part 2: Double Blind Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1 OL Creon
OL currently marketed Creon delayed release (DR) capsules for up to 35 days during a pre-randomization period.
|
Part 1 DB Creon MP / Creon
Participants received DB Creon DR capsules manufactured by modernized process (Creon MP) in treatment period 1, followed by DB currently marketed Creon DR capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 1 DB Creon / Creon MP
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon MP in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 OL Creon
OL currently marketed Creon DR capsules for up to 35 days during a pre-randomization period.
|
Part 2 DB Creon AAPIS / Creon
Participants received DB Creon DR capsules manufactured at an alternate active pharmaceutical ingredient site (Creon AAPIS) in treatment period 1, followed by DB currently marketed Creon DR Capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 DB Creon / Creon AAPIS
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon AAPIS in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Double Blind Period 1
Other, Not Specified
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Part 1 and Part 2 participants are presented separately.
Baseline characteristics by cohort
| Measure |
Part 1 DB Creon MP / Creon
n=13 Participants
Participants received DB Creon MP in treatment period 1, followed by DB currently marketed Creon DR capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 1 DB Creon / Creon MP
n=13 Participants
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon MP in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 DB Creon AAPIS / Creon
n=11 Participants
Participants received DB Creon DR capsules manufactured at an alternate active pharmaceutical ingredient site (Creon AAPIS) in treatment period 1, followed by DB currently marketed Creon DR Capsules in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Part 2 DB Creon / Creon AAPIS
n=12 Participants
Participants received DB currently marketed Creon DR capsules in treatment period 1, followed by DB Creon AAPIS in treatment period 2. Participants also received OL currently marketed Creon DR for an interval of up to 28 days between periods 1 and 2, and during a 30-day follow-up period after period 2.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Part 1 · 12 - 18 years
|
2 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
1 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
3 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Age, Customized
Part 1 · > 18 years
|
11 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
12 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
23 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Age, Customized
Part 2 · 12 - 18 years
|
—
|
—
|
1 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
0 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
1 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Age, Customized
Part 2 · > 18 years
|
—
|
—
|
10 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
12 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
22 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Sex: Female, Male
Part 1 · Female
|
7 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
6 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
13 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Sex: Female, Male
Part 1 · Male
|
6 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
7 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
13 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Sex: Female, Male
Part 2 · Female
|
—
|
—
|
6 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
3 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
9 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Sex: Female, Male
Part 2 · Male
|
—
|
—
|
5 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
9 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
14 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 1 · Hispanic or Latino
|
1 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
0 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
1 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 1 · Not Hispanic or Latino
|
12 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
13 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
25 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 1 · Unknown or Not Reported
|
0 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
0 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
0 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 2 · Hispanic or Latino
|
—
|
—
|
0 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
1 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
1 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 2 · Not Hispanic or Latino
|
—
|
—
|
11 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
11 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
22 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Ethnicity (NIH/OMB)
Part 2 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
0 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
0 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Race/Ethnicity, Customized
Part 1: White
|
13 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
13 Participants
n=13 Participants • Part 1 and Part 2 participants are presented separately.
|
—
|
—
|
26 Participants
n=26 Participants • Part 1 and Part 2 participants are presented separately.
|
|
Race/Ethnicity, Customized
Part 2: White
|
—
|
—
|
11 Participants
n=11 Participants • Part 1 and Part 2 participants are presented separately.
|
12 Participants
n=12 Participants • Part 1 and Part 2 participants are presented separately.
|
23 Participants
n=23 Participants • Part 1 and Part 2 participants are presented separately.
|
PRIMARY outcome
Timeframe: Up to Day 8 of each DB treatment periodPopulation: Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods
CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Outcome measures
| Measure |
Part 1 DB Creon
n=24 Participants
Part 1 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 1 DB Creon MP
n=24 Participants
Part 1 participants received Creon MP in treatment period 1 or 2.
|
Part 2 DB Creon
Part 2 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 2 Double-Blind Creon AAPIS
Participants received Creon DR capsules manufactured at an AAPIS in treatment periods 1 or 2.
|
|---|---|---|---|---|
|
Part 1 Coefficient of Fat Absorption (CFA)
|
85.53 percentage of fat intake absorbed
Standard Error 1.898
|
84.59 percentage of fat intake absorbed
Standard Error 1.898
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8 of each DB treatment periodPopulation: Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods
CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Outcome measures
| Measure |
Part 1 DB Creon
n=20 Participants
Part 1 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 1 DB Creon MP
n=20 Participants
Part 1 participants received Creon MP in treatment period 1 or 2.
|
Part 2 DB Creon
Part 2 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 2 Double-Blind Creon AAPIS
Participants received Creon DR capsules manufactured at an AAPIS in treatment periods 1 or 2.
|
|---|---|---|---|---|
|
Part 2 Coefficient of Fat Absorption (CFA)
|
87.74 percentage of fat intake absorbed
Standard Error 1.554
|
88.88 percentage of fat intake absorbed
Standard Error 1.554
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 8 of each DB treatment periodPopulation: Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods
The CNA is calculated as 100\*\[nitrogen intake - nitrogen excretion\]/nitrogen intake. Nitrogen intake was determined from protein content of food consumed on Day 3, 4, 5 of each treatment period. Nitrogen excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Outcome measures
| Measure |
Part 1 DB Creon
n=24 Participants
Part 1 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 1 DB Creon MP
n=24 Participants
Part 1 participants received Creon MP in treatment period 1 or 2.
|
Part 2 DB Creon
n=20 Participants
Part 2 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 2 Double-Blind Creon AAPIS
n=20 Participants
Participants received Creon DR capsules manufactured at an AAPIS in treatment periods 1 or 2.
|
|---|---|---|---|---|
|
Coefficient of Nitrogen Absorption (CNA)
|
85.01 percentage of nitrogen absorbed
Standard Error 1.058
|
85.04 percentage of nitrogen absorbed
Standard Error 1.058
|
85.67 percentage of nitrogen absorbed
Standard Error 1.223
|
86.50 percentage of nitrogen absorbed
Standard Error 1.223
|
SECONDARY outcome
Timeframe: Up to Day 8 of each DB treatment periodPopulation: Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods
Total amount of fat excreted during the stool collection period. Stool fat was determined from the stool fat in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Outcome measures
| Measure |
Part 1 DB Creon
n=24 Participants
Part 1 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 1 DB Creon MP
n=24 Participants
Part 1 participants received Creon MP in treatment period 1 or 2.
|
Part 2 DB Creon
n=20 Participants
Part 2 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 2 Double-Blind Creon AAPIS
n=20 Participants
Participants received Creon DR capsules manufactured at an AAPIS in treatment periods 1 or 2.
|
|---|---|---|---|---|
|
Stool Fat
|
44.52 grams
Standard Error 5.848
|
47.88 grams
Standard Error 5.848
|
37.46 grams
Standard Error 4.734
|
34.19 grams
Standard Error 4.734
|
SECONDARY outcome
Timeframe: Up to Day 8 of each DB treatment periodPopulation: Evaluable Set: participants who completed both treatment periods and had 100% of stool samples collected and analyzed by the laboratory in both treatment periods
Stool weight was determined from the net weight of the stool samples collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Outcome measures
| Measure |
Part 1 DB Creon
n=24 Participants
Part 1 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 1 DB Creon MP
n=24 Participants
Part 1 participants received Creon MP in treatment period 1 or 2.
|
Part 2 DB Creon
n=20 Participants
Part 2 participants received DB currently marketed Creon DR capsules in treatment period 1 or 2.
|
Part 2 Double-Blind Creon AAPIS
n=20 Participants
Participants received Creon DR capsules manufactured at an AAPIS in treatment periods 1 or 2.
|
|---|---|---|---|---|
|
Stool Weight
|
861.04 grams
Standard Error 66.630
|
826.36 grams
Standard Error 66.630
|
754.91 grams
Standard Error 87.307
|
771.47 grams
Standard Error 87.307
|
Adverse Events
Part 1 OL Creon Pre-Randomization
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 DB Creon
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 DB Creon MP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 OL Creon Post-Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 OL Creon Pre-Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 DB Creon
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 DB Creon AAPIS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 OL Creon Post-Randomization
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 OL Creon Pre-Randomization
n=31 participants at risk
OL currently marketed Creon DR capsules for up to 35 days pre-randomization.
|
Part 1 DB Creon
n=26 participants at risk
DB currently marketed Creon DR capsules in treatment period 1 or 2
|
Part 1 DB Creon MP
n=25 participants at risk
DB Creon MP capsules in treatment period 1 or 2
|
Part 1 OL Creon Post-Randomization
n=26 participants at risk
OL currently marketed Creon DR capsules post-randomization.
|
Part 2 OL Creon Pre-Randomization
n=27 participants at risk
OL currently marketed Creon DR capsules for up to 35 days pre-randomization.
|
Part 2 DB Creon
n=23 participants at risk
DB currently marketed Creon DR capsules in treatment period 1 or 2
|
Part 2 DB Creon AAPIS
n=23 participants at risk
DB Creon AAPIS capsules in treatment period 1 or 2
|
Part 2 OL Creon Post-Randomization
n=23 participants at risk
OL currently marketed Creon DR capsules post-randomization.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/31 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
3.8%
1/26 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
|
Infections and infestations
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
|
3.2%
1/31 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/31 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
4.3%
1/23 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
Other adverse events
| Measure |
Part 1 OL Creon Pre-Randomization
n=31 participants at risk
OL currently marketed Creon DR capsules for up to 35 days pre-randomization.
|
Part 1 DB Creon
n=26 participants at risk
DB currently marketed Creon DR capsules in treatment period 1 or 2
|
Part 1 DB Creon MP
n=25 participants at risk
DB Creon MP capsules in treatment period 1 or 2
|
Part 1 OL Creon Post-Randomization
n=26 participants at risk
OL currently marketed Creon DR capsules post-randomization.
|
Part 2 OL Creon Pre-Randomization
n=27 participants at risk
OL currently marketed Creon DR capsules for up to 35 days pre-randomization.
|
Part 2 DB Creon
n=23 participants at risk
DB currently marketed Creon DR capsules in treatment period 1 or 2
|
Part 2 DB Creon AAPIS
n=23 participants at risk
DB Creon AAPIS capsules in treatment period 1 or 2
|
Part 2 OL Creon Post-Randomization
n=23 participants at risk
OL currently marketed Creon DR capsules post-randomization.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/31 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
3.8%
1/26 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
8.7%
2/23 • Number of events 3 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
4.3%
1/23 • Number of events 2 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/31 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
3.8%
1/26 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
8.7%
2/23 • Number of events 2 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
|
Nervous system disorders
DIZZINESS
|
3.2%
1/31 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
8.7%
2/23 • Number of events 2 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.7%
3/31 • Number of events 3 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/25 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/26 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/27 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
0.00%
0/23 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
4.3%
1/23 • Number of events 1 • All-Cause Mortality: overall median 100.0 days. Adverse Events, Part 1 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 32 days; DB Creon: median 6 days; DB Creon MP: median 6 days; OL Creon Post-Randomization: median 53 days. Adverse Events, Part 2 (1st dose through end of given OL or DB period): OL Creon Pre-Randomization: median 26.5 days; DB Creon: median 6 days; DB Creon AAPIS: median 6 days; OL Creon Post-Randomization: median 46 days.
Events during the OL Pre-Randomization Period are reported for the Open Label Safety Analysis Set (participants who received at least 1 dose of OL Creon during any study period). In Part 1, the 31 participants include 5 screen failures who received OL Creon during the pre-randomization period. In Part 2, the 27 participants include 3 randomized participants with no record of OL Creon pre-randomization and 4 screen failures who received OL Creon during the pre-randomization period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER