Comparison · NCT01284348-80ccf43a
Sotatercept 15 mg vs Sotatercept 30 mg: Number of Participants Who Experienced One or More Adverse Events (AEs)
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: Number of Participants Who Experienced One or More Adverse Events (AEs). Trial comparisons, record NCT01284348-80ccf43a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01284348-80ccf43a
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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 | 1 | 0.785 | 1 | wilson | |
| Risk in group 2 | 0.909 | 0.623 | 0.984 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.137 | 0.377 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.913 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Sotatercept 15 mg than on Sotatercept 30 mg | 11 | 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 15 mg | Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses. | 14 | 14 | OG000 |
| Group 2 | Sotatercept 30 mg | Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses. | 10 | 11 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced One or More Adverse Events (AEs)
- Description
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
- Time frame
- Up to approximately 6 months
- Population
- All participants who received at least 1 dose of study drug
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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