Comparison · NCT04005716-sae
Arm A: Tislelizumab + Chemotherapy vs Arm B: 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. Arm A: Tislelizumab + Chemotherapy vs Arm B: Placebo + Chemotherapy: serious adverse events. Trial comparisons, record NCT04005716-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04005716-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 | 0.414 | 0.352 | 0.479 | wilson | |
| Risk in group 2 | 0.306 | 0.25 | 0.368 | wilson | |
| Risk difference, group 1 minus group 2 | 0.108 | 0.0203 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 1.06 | 1.74 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 1.09 | 2.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Tislelizumab + Chemotherapy than on Arm B: Placebo + Chemotherapy | 9.22 | 5.15 | 49.2 | 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 | Arm A: Tislelizumab + Chemotherapy | Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4. | 94 | 227 | EG000 |
| Group 2 | Arm B: Placebo + Chemotherapy | Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4. | 70 | 229 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
Source ClinicalTrials.gov
Trial
- Title
- Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT04005716
- Phases
- PHASE3
- Conditions
- Small Cell Lung Cancer
- Interventions
- Tislelizumab, Cisplatin, Carboplatin, Etoposide, Placebo
- Lead sponsor
- BeiGene
- Results first posted
- 2025-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04005716?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/NCT04005716-sae