Comparison · NCT01101451-sae
Arm I (Radiation) vs Arm II (Cisplatin + Radiation): 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 (Radiation) vs Arm II (Cisplatin + Radiation): serious adverse events. Trial comparisons, record NCT01101451-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01101451-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 | 0.0412 | 0.0201 | 0.0825 | wilson | |
| Risk in group 2 | 0.0559 | 0.0297 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0147 | -0.0662 | 0.0343 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.737 | 0.281 | 1.93 | log | |
| Odds ratio, group 1 over group 2 | 0.725 | 0.264 | 2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Radiation) than on Arm II (Cisplatin + Radiation) | 67.9 | 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 (Radiation) | Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks. | 7 | 170 | EG000 |
| Group 2 | Arm II (Cisplatin + Radiation) | Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 9 | 161 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
- NCT number
- NCT01101451
- Phases
- PHASE3
- Conditions
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage I Cervical Cancer AJCC v6 and v7, Stage IA Cervical Cancer AJCC v6 and v7, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7
- Interventions
- Cisplatin, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- Lead sponsor
- GOG Foundation
- Results first posted
- 2025-05-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01101451?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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