Comparison · NCT00473889-sae
Vorinostat + Paclitaxel + Carboplatin vs Placebo + Paclitaxel + Carboplatin: 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. Vorinostat + Paclitaxel + Carboplatin vs Placebo + Paclitaxel + Carboplatin: serious adverse events. Trial comparisons, record NCT00473889-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00473889-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 | 0.508 | 0.421 | 0.594 | wilson | |
| Risk in group 2 | 0.363 | 0.284 | 0.45 | wilson | |
| Risk difference, group 1 minus group 2 | 0.145 | 0.0218 | 0.262 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 1.05 | 1.87 | log | |
| Odds ratio, group 1 over group 2 | 1.81 | 1.09 | 3.01 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vorinostat + Paclitaxel + Carboplatin than on Placebo + Paclitaxel + Carboplatin | 6.89 | 3.81 | 45.9 | 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 | Vorinostat + Paclitaxel + Carboplatin | Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. | 63 | 124 | EG000 |
| Group 2 | Placebo + Paclitaxel + Carboplatin | Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. | 45 | 124 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
- NCT number
- NCT00473889
- Phases
- PHASE2, PHASE3
- Conditions
- Stage IIIB or IV Non-Small Cell Lung Cancer
- Interventions
- vorinostat, Comparator: paclitaxel, Comparator: carboplatin, Comparator: placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2009-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00473889?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/NCT00473889-sae