Comparison · NCT00415532-sae
AMG 531 vs Standard of Care: 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. AMG 531 vs Standard of Care: serious adverse events. Trial comparisons, record NCT00415532-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00415532-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 | 0.231 | 0.172 | 0.303 | wilson | |
| Risk in group 2 | 0.384 | 0.281 | 0.498 | wilson | |
| Risk difference, group 1 minus group 2 | -0.153 | -0.282 | -0.027 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.602 | 0.4 | 0.905 | log | |
| Odds ratio, group 1 over group 2 | 0.482 | 0.264 | 0.879 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on AMG 531 than on Standard of Care | 6.54 | 3.55 | 37 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AMG 531 | 36 | 156 | EG001 | |
| Group 2 | Standard of Care | Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks. | 28 | 73 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 week treatment period
Source ClinicalTrials.gov
Trial
- Title
- Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
- NCT number
- NCT00415532
- Phases
- PHASE3
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenic Purpura
- Interventions
- Medical Standard of Care for ITP, Romiplostim
- Lead sponsor
- Amgen
- Results first posted
- 2013-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00415532?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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