Comparison · NCT00300885-sae
Sorafenib + C/P vs Placebo + C/P: 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. Sorafenib + C/P vs Placebo + C/P: serious adverse events. Trial comparisons, record NCT00300885-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00300885-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 | 0.587 | 0.542 | 0.631 | wilson | |
| Risk in group 2 | 0.425 | 0.38 | 0.47 | wilson | |
| Risk difference, group 1 minus group 2 | 0.163 | 0.0983 | 0.225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 1.21 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 1.93 | 1.48 | 2.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sorafenib + C/P than on Placebo + C/P | 6.15 | 4.44 | 10.2 | 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 | Sorafenib + C/P | Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle. | 272 | 463 | EG000 |
| Group 2 | Placebo + C/P | Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle. | 195 | 459 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The adverse event data were collected from the first subject's first visit (13 Feb 2006) to the planned formal interim analysis (01 Oct 2007 data cut-off date), and additional safety data were collected until the last subject's last visit (05 Feb 2009).
Source ClinicalTrials.gov
Trial
- Title
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00300885
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small Cell Lung
- Interventions
- Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel, Carboplatin plus Paclitaxel
- Lead sponsor
- Bayer
- Results first posted
- 2010-09-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00300885?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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