Comparison · NCT01386658-13dceeee
Prepubertal vs Pubertal/Postpubertal: Number of Participants With Adverse Events (AEs)
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. Prepubertal vs Pubertal/Postpubertal: Number of Participants With Adverse Events (AEs). Trial comparisons, record NCT01386658-13dceeee. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01386658-13dceeee
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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 | 0.182 | 0.0514 | 0.477 | wilson | |
| Risk in group 2 | 0.524 | 0.324 | 0.717 | wilson | |
| Risk difference, group 1 minus group 2 | -0.342 | -0.575 | 0.0146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.347 | 0.0929 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 0.202 | 0.0349 | 1.17 | log | |
| Number needed to treat, for one fewer participant with the outcome on Prepubertal than on Pubertal/Postpubertal | 2.92 | from the risk difference interval | the interval includes no difference |
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 | Prepubertal | Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. | 2 | 11 | OG000 |
| Group 2 | Pubertal/Postpubertal | Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures. | 11 | 21 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Adverse Events (AEs)
- Description
An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.
- Time frame
- From the start of study drug administration up to 97 days post-dose
- Population
- Safety population consisted of participants who were treated with icatibant at least once during the study.
Source ClinicalTrials.gov
Trial
- Title
- A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
- NCT number
- NCT01386658
- Phases
- PHASE3
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- icatibant
- Lead sponsor
- Shire
- Results first posted
- 2019-03-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01386658?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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