Comparison · NCT00128102-2ccab192
Vorinostat vs Placebo: Number of Participants Who Experienced an AE
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. Vorinostat vs Placebo: Number of Participants Who Experienced an AE. Trial comparisons, record NCT00128102-2ccab192. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00128102-2ccab192
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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 | 0.994 | 0.978 | 0.998 | wilson | |
| Risk in group 2 | 0.945 | 0.915 | 0.965 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0486 | 0.0233 | 0.0791 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 1.02 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 9.46 | 2.18 | 41.1 | log | |
| Number needed to treat, for one more participant with the outcome on Vorinostat than on Placebo | 20.6 | 12.6 | 43 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vorinostat | Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity. | 327 | 329 | OG000 |
| Group 2 | Placebo | Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity. | 311 | 329 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced an AE
- Description
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who experienced an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced an AE is reported here for all randomized participants who received ≥1 dose of study treatment.
- Time frame
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- Population
- All participants randomized to a study arm who received ≥1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
- NCT number
- NCT00128102
- Phases
- PHASE3
- Conditions
- Mesothelioma, Lung Cancer
- Interventions
- Vorinostat, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2020-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00128102?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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