Comparison · NCT01727336-6bb5306b
Part 2: Dalantercept 0.9 mg/kg Plus Axitinib vs Part 2: Placebo Plus Axitinib: Part 2: Objective Response Rate.
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. Part 2: Dalantercept 0.9 mg/kg Plus Axitinib vs Part 2: Placebo Plus Axitinib: Part 2: Objective Response Rate. Trial comparisons, record NCT01727336-6bb5306b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01727336-6bb5306b
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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 | 0.109 | 0.309 | wilson | |
| Risk in group 2 | 0.246 | 0.155 | 0.367 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0562 | -0.201 | 0.0934 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.771 | 0.387 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 0.718 | 0.298 | 1.73 | log | |
| Number needed to treat, for one fewer participant with the outcome on Part 2: Dalantercept 0.9 mg/kg Plus Axitinib than on Part 2: Placebo Plus Axitinib | 17.8 | 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 | Part 2: Dalantercept 0.9 mg/kg Plus Axitinib | Subcutaneous (SC) injection of Dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing. | 11 | 58 | OG000 |
| Group 2 | Part 2: Placebo Plus Axitinib | Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing | 15 | 61 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Part 2: Objective Response Rate.
- Description
Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Time frame
- Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study
- Population
- The All Treated Set (ATS) included all randomized patients who received any study drug
Source ClinicalTrials.gov
Trial
- Title
- Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
- NCT number
- NCT01727336
- Phases
- PHASE2
- Conditions
- Advanced Renal Cell Carcinoma
- Interventions
- Dalantercept and axitinib, Placebo and axitinib
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Results first posted
- 2021-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01727336?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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