Comparison · NCT02878603-sae
Caplacizumab (Treated in Study C301) vs Standard of Care (SoC) (Treated in Study C301): serious adverse events
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. Caplacizumab (Treated in Study C301) vs Standard of Care (SoC) (Treated in Study C301): serious adverse events. Trial comparisons, record NCT02878603-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02878603-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 | 0.373 | 0.273 | 0.486 | wilson | |
| Risk in group 2 | 0.552 | 0.375 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.178 | -0.371 | 0.031 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.677 | 0.436 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.484 | 0.203 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Caplacizumab (Treated in Study C301) than on Standard of Care (SoC) (Treated in Study C301) | 5.61 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Caplacizumab (Treated in Study C301) | Participants who completed study ALX0681-C301 and received caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to IMP, withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg IV dose followed by a daily 10 mg SC injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371. | 28 | 75 | EG001 |
| Group 2 | Standard of Care (SoC) (Treated in Study C301) | Participants who completed study ALX0681-C301 with SoC (plasma exchange \[PE\], corticosteroid and other immunosuppressive agents) treatment were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product \[IMP\], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 mg intravenous (IV) dose followed by a daily 10 milligrams (mg) subcutaneous (SC) injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371. | 16 | 29 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline up to 36 months
Source ClinicalTrials.gov
Trial
- Title
- Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
- NCT number
- NCT02878603
- Phases
- PHASE3
- Conditions
- Acquired Thrombotic Thrombocytopenic Purpura
- Interventions
- Caplacizumab, Standard of Care
- Lead sponsor
- Sanofi
- Results first posted
- 2021-11-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02878603?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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