Comparison · NCT01246960-sae
Ramucirumab and mFOLFOX6 vs Placebo and mFOLFOX6: 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. Ramucirumab and mFOLFOX6 vs Placebo and mFOLFOX6: serious adverse events. Trial comparisons, record NCT01246960-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01246960-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 | 0.585 | 0.477 | 0.686 | wilson | |
| Risk in group 2 | 0.4 | 0.3 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | 0.185 | 0.0315 | 0.327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.46 | 1.06 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 2.12 | 1.13 | 3.96 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ramucirumab and mFOLFOX6 than on Placebo and mFOLFOX6 | 5.39 | 3.05 | 31.8 | from the risk difference interval |
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 | Ramucirumab and mFOLFOX6 | Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~* Oxaliplatin: 85 mg/m\^2~* Leucovorin: 400 mg/m\^2~* 5-FU: 400 mg/m\^2 bolus~* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met. | 48 | 82 | EG000 |
| Group 2 | Placebo and mFOLFOX6 | Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~* Oxaliplatin: 85 mg/m\^2~* Leucovorin: 400 mg/m\^2~* 5-FU: 400 mg/m\^2 bolus~* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met. | 32 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
- NCT number
- NCT01246960
- Phases
- PHASE2
- Conditions
- Stomach Cancer, Esophageal Cancer
- Interventions
- Ramucirumab, Placebo, Oxaliplatin, Leucovorin, 5-Fluorouracil
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2014-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01246960?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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