Comparison · NCT03268811-5de07ee6
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): 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
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ConductScience Library. Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03268811-5de07ee6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03268811-5de07ee6
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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 | 0.646 | 1 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.354 | 0.658 | 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
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Total Children (Aged: 1 to 15 Years) | Participants aged from 1 through 15 years who participated in the core study (SHP633-302 \[NCT02980666\]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. | 7 | 7 | OG000 |
| Group 2 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through \< 12 months of corrected gestational age who participated in the core study (SHP633-302 \[NCT02980666\]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. | 2 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- 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 were defined as any AEs whose onset occurred, severity worsened or intensity increased after receiving the investigational product (IP) in the core study (SHP633-302 \[NCT02980666\]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]).
- Time frame
- From Baseline up to follow-up (up to 50 months)
- Population
- The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]).
Source ClinicalTrials.gov
Trial
- Title
- A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
- NCT number
- NCT03268811
- Phases
- PHASE3
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide
- Lead sponsor
- Shire
- Results first posted
- 2022-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03268811?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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