Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

STEPS — results

Primary endpoint, absolute and relative effect where derivable, and harms as reported.

Document identifier
CEI-TR-0139/3
Series
Trial abstract
Version
2.3
Published
14 Jan 2023
Last reviewed
14 Oct 2023
Next review
14 Oct 2025
Identifier
10.71829/cei.trial.139
Certainty
Moderate
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Proportion achieving a 20 % to 100 % reduction in weekly parenteral support volume at weeks 20 and 24 in short-bowel syndrome with intestinal failureResponse in 63 % versus 30 % with placeboModerate
Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed.

§3.2Endpoint hierarchy

§3.3Harms as reported

Table 5. Adverse events for Teduglutide from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.

EventActive, %Comparator, %Source trial
Abdominal pain38.023.0STEPS
Nausea25.020.0STEPS
Injection-site reaction21.05.0STEPS
Stomal complication (in patients with a stoma)42.03.0STEPS
Fluid overload12.07.0STEPS
Colorectal polypColonoscopy required before initiation and periodically thereafter
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