Comparison · NCT00976911-sae
Chemotherapy vs Chemotherapy + 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. Chemotherapy vs Chemotherapy + Bevacizumab: serious adverse events. Trial comparisons, record NCT00976911-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00976911-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 | 0.271 | 0.211 | 0.34 | wilson | |
| Risk in group 2 | 0.313 | 0.249 | 0.384 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0421 | -0.135 | 0.0516 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.865 | 0.626 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.815 | 0.517 | 1.29 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Chemotherapy than on Chemotherapy + Bevacizumab | 23.7 | 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 | Chemotherapy | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. | 49 | 181 | EG000 |
| Group 2 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. | 56 | 179 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AEs) were recorded at every treatment visit and all follow-up visits until 2 months after the final follow-up visit (up to approximately 4 years).
Source ClinicalTrials.gov
Trial
- Title
- AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
- NCT number
- NCT00976911
- Phases
- PHASE3
- Conditions
- Ovarian Cancer
- Interventions
- Bevacizumab, liposomal doxorubicin, paclitaxel, topotecan
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2015-02-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00976911?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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