Comparison · NCT03430843-sae
Tislelizumab vs Investigator Chosen Chemotherapy (ICC): 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 vs Investigator Chosen Chemotherapy (ICC): serious adverse events. Trial comparisons, record NCT03430843-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03430843-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 | 0.427 | 0.368 | 0.489 | wilson | |
| Risk in group 2 | 0.442 | 0.38 | 0.505 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0142 | -0.101 | 0.0726 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.792 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.944 | 0.661 | 1.35 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tislelizumab than on Investigator Chosen Chemotherapy (ICC) | 70.3 | 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 | Tislelizumab | Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met. | 109 | 255 | EG000 |
| Group 2 | Investigator Chosen Chemotherapy (ICC) | Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days | 106 | 240 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- NCT number
- NCT03430843
- Phases
- PHASE3
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Tislelizumab, Paclitaxel, Docetaxel, Irinotecan
- Lead sponsor
- BeiGene
- Results first posted
- 2023-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03430843?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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