Comparison · NCT00787527-sae
Schedule A: Vorinostat Once or Twice Daily vs Schedule B: Vorinostat Three Times Daily: 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. Schedule A: Vorinostat Once or Twice Daily vs Schedule B: Vorinostat Three Times Daily: serious adverse events. Trial comparisons, record NCT00787527-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00787527-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 | 1 | 0.676 | 1 | wilson | |
| Risk in group 2 | 0.833 | 0.436 | 0.97 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.185 | 0.564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.839 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Schedule A: Vorinostat Once or Twice Daily than on Schedule B: Vorinostat Three Times Daily | 6 | from the risk difference interval | the interval includes no difference |
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 | Schedule A: Vorinostat Once or Twice Daily | Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m\^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m\^2 IV Day 1; Vincristine 1.4 mg/m\^2 IV Day 1. | 8 | 8 | EG000 |
| Group 2 | Schedule B: Vorinostat Three Times Daily | Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m\^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m\^2 IV Day 1; Vincristine 1.4 mg/m\^2 IV Day 1. | 5 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event reporting period begins once study drug treatment is initiated through 30 days after the last study treatment (21 day cycle). Overall study participation July 2009 to August 2012 for Phase I (Schedule A) and Phase II (Schedule B).
Source ClinicalTrials.gov
Trial
- Title
- SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00787527
- Phases
- PHASE1, PHASE2
- Conditions
- Lymphoma
- Interventions
- Zolinza (vorinostat), Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2014-09-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00787527?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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