Comparison · NCT01285557-sae
S-1+Cisplatin vs 5FU+Cisplatin: 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 vs 5FU+Cisplatin: serious adverse events. Trial comparisons, record NCT01285557-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01285557-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 | 0.274 | 0.22 | 0.335 | wilson | |
| Risk in group 2 | 0.263 | 0.192 | 0.349 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0112 | -0.0901 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.721 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.641 | 1.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on S-1+Cisplatin than on 5FU+Cisplatin | 89.3 | 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 | S-1+Cisplatin | Participants received S-1 25 mg/m\^2 orally BID every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m\^2 as a 1- to 3-hour IV infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier. | 63 | 230 | EG000 |
| Group 2 | 5FU+Cisplatin | Participants received 5-FU 800 mg/m\^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m\^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier. | 31 | 118 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were collected from first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months). Deaths were collected from Baseline up to end of study (up to approximately 40 months).
Source ClinicalTrials.gov
Trial
- Title
- Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
- NCT number
- NCT01285557
- Phases
- PHASE3
- Conditions
- Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
- Interventions
- S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm), Fluorouracil/cisplatin (control arm)
- Lead sponsor
- Taiho Oncology, Inc.
- Results first posted
- 2022-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01285557?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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