Comparison · NCT01747551-sae
mFOLFOX6 + Ziv-aflibercept vs mFOLFOX6 + Placebo: 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. mFOLFOX6 + Ziv-aflibercept vs mFOLFOX6 + Placebo: serious adverse events. Trial comparisons, record NCT01747551-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01747551-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 | 0.791 | 0.648 | 0.886 | wilson | |
| Risk in group 2 | 0.429 | 0.245 | 0.635 | wilson | |
| Risk difference, group 1 minus group 2 | 0.362 | 0.112 | 0.569 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.84 | 1.1 | 3.09 | log | |
| Odds ratio, group 1 over group 2 | 5.04 | 1.62 | 15.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on mFOLFOX6 + Ziv-aflibercept than on mFOLFOX6 + Placebo | 2.76 | 1.76 | 8.97 | 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 | mFOLFOX6 + Ziv-aflibercept | Patients received mFOLFOX6 and ziv-aflibercept every 2 weeks. Ziv-aflibercept 4mg/kg was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death. | 34 | 43 | EG000 |
| Group 2 | mFOLFOX6 + Placebo | Patients received mFOLFOX6 and placebo every 2 weeks. Placebo was given via intravenous (IV) infusion over 1 hour. Immediately following this was administration of mFOLFOX6: oxaliplatin 85 mg/m2 IV and leucovorin 400 mg/m2 IV were given concurrently over 120 minutes, followed by fluorouracil 400 mg/m2 IV bolus injection and then fluorouracil 2,400 mg/m2 IV infusion over 46 hours. Patients continued on treatment until radiological or clinical progression, unacceptable toxicity, or death. | 9 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were assessed day 1 of each cycle. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.
Source ClinicalTrials.gov
Trial
- Title
- FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
- NCT number
- NCT01747551
- Phases
- PHASE2
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- Oxaliplatin, Leucovorin, Fluorouracil, Ziv-aflibercept
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2018-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01747551?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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