Comparison · NCT01134614-sae
Arm A (Ipilimumab and Sargramostim) vs Arm B (Ipilimumab): 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. Arm A (Ipilimumab and Sargramostim) vs Arm B (Ipilimumab): serious adverse events. Trial comparisons, record NCT01134614-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01134614-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 | 0.475 | 0.387 | 0.564 | wilson | |
| Risk in group 2 | 0.575 | 0.486 | 0.66 | wilson | |
| Risk difference, group 1 minus group 2 | -0.1 | -0.223 | 0.0261 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.825 | 0.646 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.668 | 0.4 | 1.11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Ipilimumab and Sargramostim) than on Arm B (Ipilimumab) | 9.96 | 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 | Arm A (Ipilimumab and Sargramostim) | ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity. | 56 | 118 | EG000 |
| Group 2 | Arm B (Ipilimumab) | ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. | 69 | 120 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
- NCT number
- NCT01134614
- Phases
- PHASE2
- Conditions
Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Melanoma
- Interventions
- Ipilimumab, Sargramostim
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01134614?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01134614-sae