Trial Outcomes & Findings for Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects (NCT NCT00798967)
NCT ID: NCT00798967
Last Updated: 2021-06-03
Results Overview
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
86 participants
Primary outcome timeframe
Weeks 20 and 24
Results posted on
2021-06-03
Participant Flow
First Patient Screened - November 25, 2008; Last Patient Screened - July 13, 2010; First Patient Randomized - March 3, 2009; Last Patient Randomized - July 22, 2010; Locations - hospitals and transplant centers; Subjects must be on parenteral nutrition (PN) and/or intravenous (I.V.) fluids.
Stage 1 was screening, optimization, and stabilization periods. At screening, if the PN/I.V. volume is not stable per protocol, s/he entered an optimization period (up to 8 weeks) to find the minimally tolerated stable volume of PN/I.V.. Prior to randomization, all entered 4-8 weeks of stabilization period on that volume of PN/I.V.
Participant milestones
| Measure |
Teduglutide
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
Discontinued During Dosing Period
|
4
|
4
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Teduglutide
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Randomized in error by site
|
1
|
0
|
Baseline Characteristics
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
Baseline characteristics by cohort
| Measure |
Teduglutide
n=43 Participants
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
n=43 Participants
Matching sc dose of placebo to teduglutide
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 12.6 • n=39 Participants
|
49.7 years
STANDARD_DEVIATION 15.6 • n=41 Participants
|
50.3 years
STANDARD_DEVIATION 14.1 • n=35 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Weeks 20 and 24Population: Percentages were based on the number of subjects in the Intent to Treat (ITT) population.
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Outcome measures
| Measure |
Teduglutide
n=43 Participants
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
n=43 Participants
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Responder
|
27 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: Week 0 to last visit when data was collected.Population: Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.
Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).
Outcome measures
| Measure |
Teduglutide
n=40 Participants
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
n=43 Participants
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point
|
-4.28 Liters/Week
Standard Deviation 3.81
|
-2.38 Liters/Week
Standard Deviation 2.79
|
Adverse Events
Teduglutide
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teduglutide
n=42 participants at risk
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
n=43 participants at risk
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Infections and infestations
Adenovirus infection
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Catheter sepsis
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
General disorders
Catheter-related complication
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Catheter-related infection
|
11.9%
5/42 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Central line infection
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
General disorders
Implant site extravasation
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Infective thrombosis
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Influenza
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Rectal abscess
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Vascular disorders
Subclavian vein thrombosis
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/42 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Viral infection
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
Other adverse events
| Measure |
Teduglutide
n=42 participants at risk
0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
|
Placebo
n=43 participants at risk
Matching sc dose of placebo to teduglutide
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
21.4%
9/42 • Number of events 14 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
2.3%
1/43 • Number of events 2 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.0%
13/42 • Number of events 14 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
23.3%
10/43 • Number of events 14 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Central line systemic infections
|
16.7%
7/42 • Number of events 12 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
16.3%
7/43 • Number of events 8 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Number of events 4 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
11.6%
5/43 • Number of events 7 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
General disorders
Edema peripheral
|
16.7%
7/42 • Number of events 8 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
4.7%
2/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
General disorders
Fatigue
|
9.5%
4/42 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Flatulence
|
11.9%
5/42 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
23.8%
10/42 • Number of events 11 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
0.00%
0/43 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
12/42 • Number of events 19 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
18.6%
8/43 • Number of events 12 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
General disorders
Pyrexia
|
9.5%
4/42 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
9.3%
4/43 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
6/42 • Number of events 6 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
9.3%
4/43 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
5/42 • Number of events 5 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
9.3%
4/43 • Number of events 10 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
|
Investigations
Weight increased
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of NPS Pharmaceuticals agreements with its investigators may vary. However, NPS does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER