Comparison · NCT03884101-d7fda671
Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Who Experienced an Immune-Related Adverse Event (irAE)
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. Lenvatinib + Pembrolizumab vs Paclitaxel + Carboplatin: Number of Participants Who Experienced an Immune-Related Adverse Event (irAE). Trial comparisons, record NCT03884101-d7fda671. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03884101-d7fda671
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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 | 0.752 | 0.709 | 0.791 | wilson | |
| Risk in group 2 | 0.136 | 0.106 | 0.173 | wilson | |
| Risk difference, group 1 minus group 2 | 0.616 | 0.559 | 0.665 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.52 | 4.3 | 7.09 | log | |
| Odds ratio, group 1 over group 2 | 19.3 | 13.5 | 27.6 | log | |
| Number needed to treat, for one more participant with the outcome on Lenvatinib + Pembrolizumab than on Paclitaxel + Carboplatin | 1.62 | 1.5 | 1.79 | 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 + Pembrolizumab | Participants received lenvatinib 20 mg orally daily until disease progression or toxicity and pembrolizumab 200 mg intravenous (IV) once at the start of each 3-week treatment cycle (Q3W) for up to 35 cycles (up to \~2 years). Eligible participants who stopped initial course of pembrolizumab plus lenvatinib and achieved Stable Disease (SD) or better but progressed after discontinuation, initiated a second course of pembrolizumab 200mg IV Q3W (for up to 17 cycles \[up to \~ 1 year\]) with daily lenvatinib 20 mg orally, at investigator's discretion. Treatment with lenvatinib could have been stopped at any time in the first or second course due to toxicity or disease progression. | 316 | 420 | OG000 |
| Group 2 | Paclitaxel + Carboplatin | Participants received paclitaxel 175 mg/m\^2 IV Q3W and carboplatin area under the curve (AUC) 6 mg/ml/min IV Q3W once at the start of each 3-week treatment cycle for up to 7 cycles. Participants continued receiving treatment beyond 7 cycles at the investigator's discretion. | 56 | 411 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced an Immune-Related Adverse Event (irAE)
- Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immune-related AEs (irAEs) were AEs that were considered immune-mediated or potentially immune-mediated and are well-documented for pembrolizumab. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. Per protocol, the number of participants who experienced one or more irAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.
- Time frame
- Up to approximately 68 months
- Population
- All randomized participants who received at least one dose of study intervention were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
- NCT number
- NCT03884101
- Phases
- PHASE3
- Conditions
- Endometrial Neoplasms
- Interventions
- Lenvatinib, Pembrolizumab, Paclitaxel, Carboplatin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2024-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03884101?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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