Comparison · NCT03571516-cab412fb
Teduglutide (TED) vs Standard of Care (SOC): Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Teduglutide (TED) vs Standard of Care (SOC): Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03571516-cab412fb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03571516-cab412fb
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.566 | 1 | wilson | |
| Risk in group 2 | 1 | 0.566 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.434 | 0.434 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Teduglutide (TED) | Participants (infants) 4 to 12 months of corrected gestational aged received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection QD in addition to standard medical therapy for 24 weeks. | 5 | 5 | OG000 |
| Group 2 | Standard of Care (SOC) | Participants (infants) 4 to 12 months of corrected gestational aged received standard medical therapy for 24 weeks. | 5 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs that start or deteriorate on or after the date of the first dose of investigational product.
- Time frame
- From start of study treatment up to end of study (EOS) (up to Week 28)
- Population
Safety set consisted of all participants who met the following criteria: Teduglutide treatment arm: participants who received at least 1 dose of teduglutide and had undergone at least 1 post baseline safety assessment; Standard of care treatment arm: participants who had undergone at least 1 post baseline safety assessment.
Source ClinicalTrials.gov
Trial
- Title
- Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
- NCT number
- NCT03571516
- Phases
- PHASE3
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, Standard Medical Therapy, Syringe, Needle
- Lead sponsor
- Shire
- Results first posted
- 2021-04-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03571516?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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