Comparison · NCT00991952-sae
Irinotecan Hydrochloride and Alvocidib vs Irinotecan Hydrochloride: 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. Irinotecan Hydrochloride and Alvocidib vs Irinotecan Hydrochloride: serious adverse events. Trial comparisons, record NCT00991952-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00991952-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 | 0.462 | 0.232 | 0.709 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0.128 | -0.304 | 0.47 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 0.387 | 4.95 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 0.228 | 12.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Irinotecan Hydrochloride and Alvocidib than on Irinotecan Hydrochloride | 7.8 | 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 | Irinotecan Hydrochloride and Alvocidib | Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8 | 6 | 13 | EG000 |
| Group 2 | Irinotecan Hydrochloride | Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 | 2 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery
- NCT number
- NCT00991952
- Phases
- PHASE2
- Conditions
Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage IIIA Gastric Cancer, Stage IIIB Gastric Cancer, Stage IIIC Gastric Cancer, Stage IV Gastric Cancer
- Interventions
- alvocidib, irinotecan hydrochloride, laboratory biomarker analysis
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2014-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00991952?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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