Comparison · NCT04697628-sae
Tisotumab Vedotin vs 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. Tisotumab Vedotin vs Chemotherapy: serious adverse events. Trial comparisons, record NCT04697628-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04697628-sae
On this page
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 | 0.328 | 0.273 | 0.388 | wilson | |
| Risk in group 2 | 0.393 | 0.334 | 0.456 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0653 | -0.149 | 0.0197 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.834 | 0.658 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.753 | 0.52 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tisotumab Vedotin than on Chemotherapy | 15.3 | 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 | Tisotumab Vedotin | Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W). | 82 | 250 | EG000 |
| Group 2 | Chemotherapy | Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days. | 94 | 239 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)
Source ClinicalTrials.gov
Trial
- Title
- Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
- NCT number
- NCT04697628
- Phases
- PHASE3
- Conditions
- Cervical Cancer
- Interventions
- tisotumab vedotin, topotecan, vinorelbine, gemcitabine, irinotecan, pemetrexed
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Results first posted
- 2024-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04697628?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04697628-sae