Comparison · NCT00865189-sae
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) vs Arm B (Bevacizumab, Chemoradiotherapy): 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 (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) vs Arm B (Bevacizumab, Chemoradiotherapy): serious adverse events. Trial comparisons, record NCT00865189-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00865189-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 | 0.457 | 0.322 | 0.598 | wilson | |
| Risk in group 2 | 0.4 | 0.27 | 0.545 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0565 | -0.142 | 0.249 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.708 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.548 | 2.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) than on Arm B (Bevacizumab, Chemoradiotherapy) | 17.7 | 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 (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique. | 21 | 46 | EG000 |
| Group 2 | Arm B (Bevacizumab, Chemoradiotherapy) | In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique. | 18 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to approximately 6 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
- NCT number
- NCT00865189
- Phases
- PHASE2
- Conditions
- Rectal Cancer
- Interventions
- Bevacizumab, Oxaliplatin, Folinic Acid, 5-fluorouracil, Preoperative Radiotherapy, Surgery
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2017-08-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00865189?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/NCT00865189-sae