Comparison · NCT03065244-sae
IVIG vs Infliximab: 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. IVIG vs Infliximab: serious adverse events. Trial comparisons, record NCT03065244-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03065244-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 | 0.551 | 0.413 | 0.681 | wilson | |
| Risk in group 2 | 0.185 | 0.104 | 0.308 | wilson | |
| Risk difference, group 1 minus group 2 | 0.366 | 0.181 | 0.52 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.98 | 1.61 | 5.5 | log | |
| Odds ratio, group 1 over group 2 | 5.4 | 2.22 | 13.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IVIG than on Infliximab | 2.73 | 1.92 | 5.53 | from the risk difference interval |
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 | IVIG | Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion~IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours | 27 | 49 | EG000 |
| Group 2 | Infliximab | Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours~Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours | 10 | 54 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
Source ClinicalTrials.gov
Trial
- Title
- KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
- NCT number
- NCT03065244
- Phases
- PHASE3
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Interventions
- IVIG, Infliximab
- Lead sponsor
- University of California, San Diego
- Results first posted
- 2021-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03065244?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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GET https://conductscience.org/api/comparisons/v1/NCT03065244-sae