Comparison · NCT01414608-sae
Standard Chemoradiation vs Standard Chemoradiation With Adjuvant Chemotherapy: 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. Standard Chemoradiation vs Standard Chemoradiation With Adjuvant Chemotherapy: serious adverse events. Trial comparisons, record NCT01414608-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01414608-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 | 0.216 | 0.181 | 0.257 | wilson | |
| Risk in group 2 | 0.296 | 0.252 | 0.345 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0801 | -0.141 | -0.0199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.73 | 0.576 | 0.925 | log | |
| Odds ratio, group 1 over group 2 | 0.655 | 0.477 | 0.901 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Chemoradiation than on Standard Chemoradiation With Adjuvant Chemotherapy | 12.5 | 7.11 | 50.3 | 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 | Standard Chemoradiation | 45 - 50.4 Gy external beam radiation therapy (EBRT) delivered in fractions of 1.8 Gy to the pelvis, followed by brachytherapy. Cisplatin given during the radiation at a dose of 40mg/m2 weekly for 5 doses. At risk population includes eligible participants who received at least one dose of cisplatin and/or any dose of radiotherapy. | 98 | 453 | EG000 |
| Group 2 | Standard Chemoradiation With Adjuvant Chemotherapy | 45 - 50.4 Gy external beam radiation therapy (EBRT) delivered in fractions of 1.8 Gy to the pelvis, followed by brachytherapy. Cisplatin given during the radiation at a dose of 40mg/m2 weekly for 5 doses to all patients. Within 4 weeks of completion of all radiation treatment, and following recovery from toxicities, participants were treated with an additional 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin AUC 5 and paclitaxel 155 mg/m2. At risk population includes eligible participants who received at least one dose of adjuvant chemotherapy (carboplatin, paclitaxel, cisplatin or docetaxel). | 107 | 361 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion with a median follow-up being 60 months.
Source ClinicalTrials.gov
Trial
- Title
- Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
- NCT number
- NCT01414608
- Phases
- PHASE3
- Conditions
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7
- Interventions
- Brachytherapy, Carboplatin, Cisplatin, External Beam Radiation Therapy, Paclitaxel, Quality-of-Life Assessment
- Lead sponsor
- GOG Foundation
- Results first posted
- 2022-11-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01414608?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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