Comparison · NCT00946712-sae
Arm I (Chemo +/- Bevacizumab) vs Arm II (Chemo, Cetuximab, +/- 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
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ConductScience Library. Arm I (Chemo +/- Bevacizumab) vs Arm II (Chemo, Cetuximab, +/- Bevacizumab): serious adverse events. Trial comparisons, record NCT00946712-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00946712-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 | 0.104 | 0.0829 | 0.131 | wilson | |
| Risk in group 2 | 0.155 | 0.129 | 0.185 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0503 | -0.0875 | -0.0132 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.675 | 0.504 | 0.904 | log | |
| Odds ratio, group 1 over group 2 | 0.637 | 0.456 | 0.89 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Chemo +/- Bevacizumab) than on Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 19.9 | 11.4 | 75.9 | 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 | Arm I (Chemo +/- Bevacizumab) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV | 66 | 632 | EG000 |
| Group 2 | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Cetuximab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV | 97 | 627 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Toxicity assessment was evaluated every 3 weeks while on protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression, an average of 6 months.
Source ClinicalTrials.gov
Trial
- Title
- S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
- NCT number
- NCT00946712
- Phases
- PHASE3
- Conditions
Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma, Stage IV Large Cell Lung Carcinoma, Stage IV Lung Adenocarcinoma, Stage IV Squamous Cell Lung Carcinoma
- Interventions
- Bevacizumab, Carboplatin, Cetuximab, Laboratory Biomarker Analysis, Paclitaxel
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2019-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00946712?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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