Comparison · NCT01284348-sae
Sotatercept 15 mg vs Sotatercept 30 mg: 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. Sotatercept 15 mg vs Sotatercept 30 mg: serious adverse events. Trial comparisons, record NCT01284348-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01284348-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 | 0.286 | 0.117 | 0.546 | wilson | |
| Risk in group 2 | 0.727 | 0.434 | 0.903 | wilson | |
| Risk difference, group 1 minus group 2 | -0.442 | -0.685 | -0.0494 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.393 | 0.159 | 0.97 | log | |
| Odds ratio, group 1 over group 2 | 0.15 | 0.0258 | 0.874 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sotatercept 15 mg than on Sotatercept 30 mg | 2.26 | 1.46 | 20.3 | 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 | Sotatercept 15 mg | Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses. | 4 | 14 | EG000 |
| Group 2 | Sotatercept 30 mg | Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses. | 8 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 6 months
Source ClinicalTrials.gov
Trial
- Title
- To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
- NCT number
- NCT01284348
- Phases
- PHASE2
- Conditions
- Anemia, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small-Cell Lung, Bladder Cancer, Cancer of Head and Neck, Uterine Cervical Cancer
- Interventions
- Sotatercept 15 mg, Sotatercept 30 mg
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01284348?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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