Comparison · NCT01879085-sae
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day vs Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day: 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. Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day vs Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day: serious adverse events. Trial comparisons, record NCT01879085-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01879085-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 | 0.613 | 0.438 | 0.763 | wilson | |
| Risk in group 2 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk difference, group 1 minus group 2 | 0.113 | -0.245 | 0.459 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.525 | 2.86 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.274 | 9.17 | log | |
Number needed to harm, for one more participant with a serious adverse event on Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day than on Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 8.86 | 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 | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | Dose Level 1:~Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).~Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).~Vorinostat: 300 mg daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).~Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg. | 19 | 31 | EG000 |
| Group 2 | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | Dose Level 2:~Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).~Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).~Vorinostat: 200 mg twice daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).~Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg. | 3 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Source ClinicalTrials.gov
Trial
- Title
- Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
- NCT number
- NCT01879085
- Phases
- PHASE1, PHASE2
- Conditions
- Sarcoma
- Interventions
- Docetaxel, Gemcitabine, Vorinostat, Pegfilgrastim
- Lead sponsor
- Melissa Burgess, MD
- Results first posted
- 2022-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01879085?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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