Comparison · NCT03829319-406f8415
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib vs Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo: Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
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. Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib vs Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo: Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event. Trial comparisons, record NCT03829319-406f8415. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03829319-406f8415
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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 | 0.34 | 0.294 | 0.39 | wilson | |
| Risk in group 2 | 0.247 | 0.206 | 0.294 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0932 | 0.0277 | 0.158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 1.1 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 1.57 | 1.14 | 2.16 | log | |
| Number needed to treat, for one more participant with the outcome on Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib than on Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 10.7 | 6.35 | 36 | 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 | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily. | 127 | 373 | OG000 |
| Group 2 | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily. | 92 | 372 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
- Description
An adverse event is defined as 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. The number of participants who discontinued study treatment during Part 2 of this study were presented.
- Time frame
- Up to approximately 58 months
- Population
- The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention.
Source ClinicalTrials.gov
Trial
- Title
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
- NCT number
- NCT03829319
- Phases
- PHASE3
- Conditions
- Nonsquamous Non-small Cell Lung Cancer
- Interventions
- Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed, Lenvatinib, Placebo matching lenvatinib
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2025-02-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03829319?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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