Comparison · NCT04154956-sae
Tusamitamab Ravtansine vs Docetaxel: 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. Tusamitamab Ravtansine vs Docetaxel: serious adverse events. Trial comparisons, record NCT04154956-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04154956-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 | 0.284 | 0.225 | 0.351 | wilson | |
| Risk in group 2 | 0.384 | 0.316 | 0.458 | wilson | |
| Risk difference, group 1 minus group 2 | -0.101 | -0.195 | -0.00477 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.738 | 0.551 | 0.987 | log | |
| Odds ratio, group 1 over group 2 | 0.634 | 0.411 | 0.98 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tusamitamab Ravtansine than on Docetaxel | 9.93 | 5.14 | 210 | 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 | Tusamitamab Ravtansine | Participants received tusamitamab ravtansine 100 mg/m\^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks). | 55 | 194 | EG000 |
| Group 2 | Docetaxel | Participants received docetaxel 75 mg/m\^2 by IV infusion, once Q3W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks). | 68 | 177 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
TEAEs were collected from date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks. All-cause mortality data was collected from date of first study treatment administration (Day 1) until the primary analysis date of 22 September 2023 (up to 189 weeks).
Source ClinicalTrials.gov
Trial
- Title
- SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
- NCT number
- NCT04154956
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- SAR408701, Docetaxel
- Lead sponsor
- Sanofi
- Results first posted
- 2024-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04154956?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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