Comparison · NCT03783442-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
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ConductScience Library. Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: serious adverse events. Trial comparisons, record NCT03783442-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03783442-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 | 0.494 | 0.44 | 0.548 | wilson | |
| Risk in group 2 | 0.399 | 0.347 | 0.453 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0951 | 0.0183 | 0.17 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 1.04 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 1.08 | 2.01 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tislelizumab + Chemotherapy than on Placebo + Chemotherapy | 10.5 | 5.87 | 54.5 | 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 tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. | 160 | 324 | EG000 |
| Group 2 | Placebo + Chemotherapy | Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. | 128 | 321 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from randomization until the end of study, maximum time on study was 63.6 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 63.5 months.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- NCT number
- NCT03783442
- Phases
- PHASE3
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Cisplatin, Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Paclitaxel, Tislelizumab, Placebo
- Lead sponsor
- BeiGene
- Results first posted
- 2023-11-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03783442?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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