Trial abstract · §3
STEPS-2 — results
Primary endpoint, absolute and relative effect where derivable, and harms as reported.
§3Results
§3.1Primary endpoint
Table 3. Primary endpoint as reported.
| Endpoint | Result as reported | Certainty |
|---|---|---|
| Sustained reduction in parenteral support volume during open-label extension | Reductions were maintained during extended open-label treatment; the Institute records extension data as descriptive rather than comparative | Moderate |
| 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.
| Event | Active, % | Comparator, % | Source trial |
|---|---|---|---|
| Abdominal pain | 38.0 | 23.0 | STEPS |
| Nausea | 25.0 | 20.0 | STEPS |
| Injection-site reaction | 21.0 | 5.0 | STEPS |
| Stomal complication (in patients with a stoma) | 42.0 | 3.0 | STEPS |
| Fluid overload | 12.0 | 7.0 | STEPS |
| Colorectal polyp | — | — | Colonoscopy required before initiation and periodically thereafter |
Compound Evidence Institute · CEI-TR-0140/3 · https://compoundevidence.com/trials/steps-2/results/ · retrieved 30 July 2026