Comparison · NCT00303628-sae
Arm I (Oxaliplatin, Fluorouracil, Leucovorin) vs Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab): 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 I (Oxaliplatin, Fluorouracil, Leucovorin) vs Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab): serious adverse events. Trial comparisons, record NCT00303628-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00303628-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 | 0.688 | 0.615 | 0.752 | wilson | |
| Risk in group 2 | 0.707 | 0.635 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.019 | -0.115 | 0.0772 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.973 | 0.847 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.914 | 0.578 | 1.44 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Oxaliplatin, Fluorouracil, Leucovorin) than on Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | 52.5 | 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 I (Oxaliplatin, Fluorouracil, Leucovorin) | Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses\* in the absence of disease progression or unacceptable toxicity. | 119 | 173 | EG000 |
| Group 2 | Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab) | Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I | 123 | 174 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every cycle (1 cycle=2 weeks) while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
- NCT number
- NCT00303628
- Phases
- PHASE3
- Conditions
- Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
- Interventions
- oxaliplatin, fluorouracil, leucovorin calcium, bevacizumab
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Results first posted
- 2016-02-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00303628?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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