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Comparison · NCT02980666-73e726d2

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 NCT02980666-73e726d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02980666-73e726d2

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 110.6761wilson
Risk in group 210.3421wilson
Risk difference, group 1 minus group 20-0.3240.658newcombe hybrid score
Risk ratio, group 1 over group 2111log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Total Children (Aged: 1 to 15 Years)Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28.88OG000
Group 2Infants (Corrected Gestational Age: 4 to < 12 Months)Participants (Infants) from 4 through \< 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28.22OG001

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.
Time frame
From start of study drug administration up to EOS (up to Week 28)
Population
Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up.

Source ClinicalTrials.gov

Trial

Title
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
NCT number
NCT02980666
Phases
PHASE3
Conditions
Short Bowel Syndrome
Interventions
Teduglutide
Lead sponsor
Shire
Results first posted
2021-02-10

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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