Comparison · NCT00538785-sae
Motavizumab (MEDI-524) vs Palivizumab: 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. Motavizumab (MEDI-524) vs Palivizumab: serious adverse events. Trial comparisons, record NCT00538785-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00538785-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 | 0.472 | 0.433 | 0.512 | wilson | |
| Risk in group 2 | 0.497 | 0.457 | 0.536 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0242 | -0.0798 | 0.0315 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.951 | 0.848 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.907 | 0.726 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Motavizumab (MEDI-524) than on Palivizumab | 41.3 | 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 | Motavizumab (MEDI-524) | Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. | 292 | 618 | EG000 |
| Group 2 | Palivizumab | Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. | 304 | 612 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 0 - Day 150
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
- NCT number
- NCT00538785
- Phases
- PHASE2
- Conditions
- Congenital Heart Disease
- Interventions
- Motavizumab, Palivizumab
- Lead sponsor
- MedImmune LLC
- Results first posted
- 2012-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00538785?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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