Comparison · NCT02466971-sae
Arm I (Cisplatin, IMRT or RT, Brachytherapy) vs Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Arm I (Cisplatin, IMRT or RT, Brachytherapy) vs Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine): serious adverse events. Trial comparisons, record NCT02466971-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02466971-sae
On this page
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 | 0.216 | 0.166 | 0.277 | wilson | |
| Risk in group 2 | 0.223 | 0.171 | 0.285 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00643 | -0.0866 | 0.0735 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.971 | 0.674 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 0.963 | 0.603 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Cisplatin, IMRT or RT, Brachytherapy) than on Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 156 | 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 | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.~Brachytherapy: Undergo brachytherapy~Cisplatin: Given IV~External Beam Radiation Therapy: Undergo EBRT~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo conventional RT | 45 | 208 | EG000 |
| Group 2 | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.~Brachytherapy: Undergo brachytherapy~Cisplatin: Given IV~Intensity-Modulated Radiation Therapy: Undergo IMRT~Laboratory Biomarker Analysis: Correlative studies~Radiation Therapy: Undergo conventional RT~Triapine: Given IV | 45 | 202 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
Source ClinicalTrials.gov
Trial
- Title
- Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
- NCT number
- NCT02466971
- Phases
- PHASE3
- Conditions
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IV Vaginal Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7, Unresectable Vaginal Carcinoma, Vaginal Adenocarcinoma, Vaginal Adenosquamous Carcinoma, Vaginal Carcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
- Interventions
- Brachytherapy, Cisplatin, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Radiation Therapy, Triapine
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02466971?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02466971-sae