Comparison · NCT00770874-sae
S-1 + Cisplatin (Arm A) vs Cisplatin (Arm B): 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. S-1 + Cisplatin (Arm A) vs Cisplatin (Arm B): serious adverse events. Trial comparisons, record NCT00770874-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00770874-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 | 0.383 | 0.316 | 0.454 | wilson | |
| Risk in group 2 | 0.194 | 0.142 | 0.259 | wilson | |
| Risk difference, group 1 minus group 2 | 0.189 | 0.0958 | 0.277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.97 | 1.39 | 2.8 | log | |
| Odds ratio, group 1 over group 2 | 2.57 | 1.6 | 4.14 | log | |
| Number needed to harm, for one more participant with a serious adverse event on S-1 + Cisplatin (Arm A) than on Cisplatin (Arm B) | 5.3 | 3.61 | 10.4 | 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 | S-1 + Cisplatin (Arm A) | S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks. | 72 | 188 | EG000 |
| Group 2 | Cisplatin (Arm B) | Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks. | 34 | 175 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of the first treatment to 30 days after the last treatment
Source ClinicalTrials.gov
Trial
- Title
- Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
- NCT number
- NCT00770874
- Phases
- PHASE3
- Conditions
- Cervical Cancer
- Interventions
- S-1 + Cisplatin (arm A), Cisplatin (arm B)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Results first posted
- 2019-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00770874?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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