Comparison · NCT00434642-sae
Carboplatin and Gemcitabine + Bevacizumab vs Carboplatin and Gemcitabine + 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
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ConductScience Library. Carboplatin and Gemcitabine + Bevacizumab vs Carboplatin and Gemcitabine + Placebo: serious adverse events. Trial comparisons, record NCT00434642-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00434642-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 | 0.364 | 0.307 | 0.426 | wilson | |
| Risk in group 2 | 0.253 | 0.202 | 0.313 | wilson | |
| Risk difference, group 1 minus group 2 | 0.111 | 0.0284 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 1.09 | 1.89 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 1.14 | 2.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Carboplatin and Gemcitabine + Bevacizumab than on Carboplatin and Gemcitabine + Placebo | 9 | 5.22 | 35.2 | 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 | Carboplatin and Gemcitabine + Bevacizumab | Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study. | 90 | 247 | EG000 |
| Group 2 | Carboplatin and Gemcitabine + Placebo | Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles. | 59 | 233 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization through July 19, 2013
Source ClinicalTrials.gov
Trial
- Title
- A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
- NCT number
- NCT00434642
- Phases
- PHASE3
- Conditions
- Ovarian Cancer
- Interventions
- Carboplatin, Gemcitabine, Bevacizumab, Placebo
- Lead sponsor
- Genentech, Inc.
- Results first posted
- 2011-11-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00434642?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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