Comparison · NCT04576988-97bc30a5
Sotatercept Plus Background PAH Therapy (DBPC Period) vs Placebo Plus Background PAH Therapy (DBPC Period): Number of Participants Who Experienced an Adverse Event (AE)
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. Sotatercept Plus Background PAH Therapy (DBPC Period) vs Placebo Plus Background PAH Therapy (DBPC Period): Number of Participants Who Experienced an Adverse Event (AE). Trial comparisons, record NCT04576988-97bc30a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04576988-97bc30a5
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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 | 0.847 | 0.783 | 0.894 | wilson | |
| Risk in group 2 | 0.875 | 0.815 | 0.918 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0284 | -0.105 | 0.0482 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.886 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.789 | 0.419 | 1.49 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sotatercept Plus Background PAH Therapy (DBPC Period) than on Placebo Plus Background PAH Therapy (DBPC Period) | 35.2 | 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 Plus Background PAH Therapy (DBPC Period) | Participants received a starting dose of sotatercept 0.3 mg/kg titrated up to 0.7mg/kg by subcutaneous (SC) injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. | 138 | 163 | OG000 |
| Group 2 | Placebo Plus Background PAH Therapy (DBPC Period) | Participants received dose matched placebo by SC injection every 21 days plus background PAH therapy during the DBPC period for up to approximately 24 weeks. | 140 | 160 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced an Adverse Event (AE)
- Description
An AE was any untoward medical occurrence in a study participant administered a study drug, which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it was considered related to the study drug. Per protocol, the number of participants who reported an AE were reported for DBPC period.
- Time frame
- Up to approximately 24 weeks
- Population
- All randomized participants who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
- NCT number
- NCT04576988
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sotatercept, Placebo, Background PAH Therapy
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Results first posted
- 2023-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04576988?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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