Comparison · NCT01041404-sae
Fluoropyrimidine/Cisplatin (FP) vs Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H): 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. Fluoropyrimidine/Cisplatin (FP) vs Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H): serious adverse events. Trial comparisons, record NCT01041404-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01041404-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 | 0.279 | 0.231 | 0.334 | wilson | |
| Risk in group 2 | 0.361 | 0.308 | 0.417 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0812 | -0.156 | -0.00555 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.775 | 0.61 | 0.984 | log | |
| Odds ratio, group 1 over group 2 | 0.687 | 0.484 | 0.975 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fluoropyrimidine/Cisplatin (FP) than on Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 12.3 | 6.43 | 180 | 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 | Fluoropyrimidine/Cisplatin (FP) | Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15. | 81 | 290 | EG000 |
| Group 2 | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15. | 106 | 294 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
Source ClinicalTrials.gov
Trial
- Title
- ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
- NCT number
- NCT01041404
- Phases
- PHASE3
- Conditions
- Gastric Cancer
- Interventions
- Trastuzumab, Fluorouracil, Cisplatin, Capecitabine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2014-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01041404?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.
For software
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