Comparison · NCT00980954-sae
Arm I: Cisplatin/Radiation Therapy vs Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel: 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. Arm I: Cisplatin/Radiation Therapy vs Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel: serious adverse events. Trial comparisons, record NCT00980954-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00980954-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 | 0.131 | 0.0796 | 0.208 | wilson | |
| Risk in group 2 | 0.248 | 0.174 | 0.34 | wilson | |
| Risk difference, group 1 minus group 2 | -0.117 | -0.222 | -0.0101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.529 | 0.292 | 0.958 | log | |
| Odds ratio, group 1 over group 2 | 0.458 | 0.223 | 0.941 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I: Cisplatin/Radiation Therapy than on Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 8.57 | 4.5 | 99.3 | from the risk difference interval |
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/Radiation Therapy | Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional. | 14 | 107 | EG000 |
| Group 2 | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity. | 25 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
- NCT number
- NCT00980954
- Phases
- PHASE3
- Conditions
- Cervical Cancer
- Interventions
- carboplatin, cisplatin, paclitaxel, intensity-modulated radiation therapy, standard external beam radiation therapy, Optional brachytherapy boost
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2024-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00980954?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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GET https://conductscience.org/api/comparisons/v1/NCT00980954-sae