Comparison · NCT03517449-e4f01beb
Lenvatinib 20 mg + Pembrolizumab 200 mg vs Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel: Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants
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. Lenvatinib 20 mg + Pembrolizumab 200 mg vs Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel: Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants. Trial comparisons, record NCT03517449-e4f01beb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03517449-e4f01beb
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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 | 0.409 | 0.359 | 0.462 | wilson | |
| Risk in group 2 | 0.129 | 0.097 | 0.17 | wilson | |
| Risk difference, group 1 minus group 2 | 0.28 | 0.215 | 0.342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.17 | 2.32 | 4.32 | log | |
| Odds ratio, group 1 over group 2 | 4.67 | 3.16 | 6.89 | log | |
| Number needed to treat, for one more participant with the outcome on Lenvatinib 20 mg + Pembrolizumab 200 mg than on Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 3.57 | 2.92 | 4.65 | 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 | Lenvatinib 20 mg + Pembrolizumab 200 mg | Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study | 140 | 342 | OG000 |
| Group 2 | Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study. | 42 | 325 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants
- Description
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- Time frame
- Up to approximately 77 months
- Population
Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
- NCT number
- NCT03517449
- Phases
- PHASE3
- Conditions
- Endometrial Neoplasms
- Interventions
- Pembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2021-11-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03517449?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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