Comparison · NCT03496207-e04b540f
Continued Sotatercept Treatment Group vs Placebo-Crossed Treatment Group: Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
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. Continued Sotatercept Treatment Group vs Placebo-Crossed Treatment Group: Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis). Trial comparisons, record NCT03496207-e04b540f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03496207-e04b540f
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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 | 0.409 | 0.299 | 0.53 | wilson | |
| Risk in group 2 | 0.552 | 0.375 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.143 | -0.34 | 0.0708 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.741 | 0.479 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.563 | 0.233 | 1.36 | log | |
| Number needed to treat, for one fewer participant with the outcome on Continued Sotatercept Treatment Group than on Placebo-Crossed Treatment Group | 7.01 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Continued Sotatercept Treatment Group | Participants who were randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg or 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Continued Sotatercept Treatment Group combined participants who received 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC. Each cycle was 21 days. Dosing occurred once every 3 weeks. | 27 | 66 | OG001 |
| Group 2 | Placebo-Crossed Treatment Group | Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks. | 16 | 29 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
- Description
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
- Time frame
- Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
- Population
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class (Delayed-Start Analysis)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT03496207
- Phases
- PHASE2
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Placebo, Sotatercept, SOC
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Results first posted
- 2023-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03496207?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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