Comparison · NCT00760435-sae
Infliximab Arm vs Placebo Arm: serious adverse events
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. Infliximab Arm vs Placebo Arm: serious adverse events. Trial comparisons, record NCT00760435-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00760435-sae
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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 | 0.224 | 0.153 | 0.317 | wilson | |
| Risk in group 2 | 0.173 | 0.111 | 0.26 | wilson | |
| Risk difference, group 1 minus group 2 | 0.051 | -0.0614 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.734 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.681 | 2.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Infliximab Arm than on Placebo Arm | 19.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Infliximab Arm | 98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once | 22 | 98 | EG000 |
| Group 2 | Placebo Arm | 98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug) | 17 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 10 weeks
Source ClinicalTrials.gov
Trial
- Title
- Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
- NCT number
- NCT00760435
- Phases
- PHASE3
- Conditions
- Kawasaki Disease
- Interventions
- Infliximab, Placebo
- Lead sponsor
- University of California, San Diego
- Results first posted
- 2014-11-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00760435?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00760435-sae