Comparison · NCT03738150-sae
Sotatercept Treatment Period vs Sotatercept Extension Period: 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 Treatment Period vs Sotatercept Extension Period: serious adverse events. Trial comparisons, record NCT03738150-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03738150-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 | 0.19 | 0.0767 | 0.4 | wilson | |
| Risk in group 2 | 0.1 | 0.0279 | 0.301 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0905 | -0.141 | 0.312 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.9 | 0.391 | 9.28 | log | |
| Odds ratio, group 1 over group 2 | 2.12 | 0.342 | 13.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sotatercept Treatment Period than on Sotatercept Extension Period | 11.1 | 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 | Sotatercept Treatment Period | Each participant received standard of care (SOC) plus sotatercept at a dose of 0.3 mg/kg SC during Cycle 1. (Each cycle was 21 days.) For the remainder of the 24-week treatment period (Cycle 2 through Cycle 9), participants received an escalated dose of 0.7 mg/kg SC. Dosing occurred once every 3 weeks. | 4 | 21 | EG000 |
| Group 2 | Sotatercept Extension Period | Each participant received standard of care (SOC) plus sotatercept at a dose of 0.7 mg/kg SC once every 3 weeks during the 18-month extension period. | 2 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment period: Up to 24 weeks; Extension period: Up to 18 months plus 8-week follow-up period.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
- NCT number
- NCT03738150
- Phases
- PHASE2
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sotatercept, SOC
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Results first posted
- 2023-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03738150?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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