Comparison · NCT02314117-sae
LY3009806+Capecitabine+Cisplatin vs Placebo+Capecitabine+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
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ConductScience Library. LY3009806+Capecitabine+Cisplatin vs Placebo+Capecitabine+Cisplatin: serious adverse events. Trial comparisons, record NCT02314117-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02314117-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 | 0.498 | 0.444 | 0.553 | wilson | |
| Risk in group 2 | 0.476 | 0.422 | 0.531 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0223 | -0.055 | 0.0992 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.893 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.801 | 1.49 | log | |
| Number needed to harm, for one more participant with a serious adverse event on LY3009806+Capecitabine+Cisplatin than on Placebo+Capecitabine+Cisplatin | 44.9 | 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 | LY3009806+Capecitabine+Cisplatin | 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m\^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. | 161 | 323 | EG000 |
| Group 2 | Placebo+Capecitabine+Cisplatin | Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m\^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day 5-FU IV on days 1 to 5 of each 21-day cycle. | 150 | 315 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline Up To 5.6 Years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
- NCT number
- NCT02314117
- Phases
- PHASE3
- Conditions
- Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Interventions
- Ramucirumab, Capecitabine, Cisplatin, Placebo, Fluorouracil
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2018-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02314117?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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