Comparison · NCT03777657-sae
Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: 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. Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: serious adverse events. Trial comparisons, record NCT03777657-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03777657-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 | 0.424 | 0.381 | 0.468 | wilson | |
| Risk in group 2 | 0.362 | 0.321 | 0.406 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0613 | 0.000567 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 1 | 1.37 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 1 | 1.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tislelizumab + Chemotherapy than on Placebo + Chemotherapy | 16.3 | 8.23 | 1,760 | 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 | Tislelizumab + Chemotherapy | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. | 211 | 498 | EG000 |
| Group 2 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. | 179 | 494 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
Source ClinicalTrials.gov
Trial
- Title
- Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
- NCT number
- NCT03777657
- Phases
- PHASE3
- Conditions
- Gastric, or Gastroesophageal Junction Adenocarcinoma
- Interventions
- Tislelizumab, Placebo, Cisplatin, Oxaliplatin, Capecitabine, 5-Fluorouracil
- Lead sponsor
- BeiGene
- Results first posted
- 2025-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03777657?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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GET https://conductscience.org/api/comparisons/v1/NCT03777657-sae