Comparison · NCT03268811-84e0a006
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Abnormalities in Vital Signs
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. Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Abnormalities in Vital Signs. Trial comparisons, record NCT03268811-84e0a006. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03268811-84e0a006
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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 | 0 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.354 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| 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. | 0 | 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. | 0 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Abnormalities in Vital Signs
- Description
Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator 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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