Comparison · NCT00538785-c29ad445
Motavizumab (MEDI-524) vs Palivizumab: Number of Subjects Reporting Serious Adverse Events Through Study Day 150
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. Motavizumab (MEDI-524) vs Palivizumab: Number of Subjects Reporting Serious Adverse Events Through Study Day 150. Trial comparisons, record NCT00538785-c29ad445. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00538785-c29ad445
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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 the outcome 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 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects Reporting Serious Adverse Events Through Study Day 150
- Description
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
- Time frame
- Days 0-150
- Population
- The Safety population included all subjects who received any study drug and had any safety follow-up.
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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