Comparison · NCT03829319-a0729d46
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib vs Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo: Part 2: Number of Participants Who Experienced an Adverse Event (AE)
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 Experienced an Adverse Event (AE). Trial comparisons, record NCT03829319-a0729d46. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03829319-a0729d46
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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 | 0.997 | 0.985 | 1 | wilson | |
| Risk in group 2 | 0.995 | 0.981 | 0.999 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0027 | -0.0103 | 0.0169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.994 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.182 | 22.3 | 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 | 371 | 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 | 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. | 372 | 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. | 370 | 372 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Part 2: Number of Participants Who Experienced an Adverse Event (AE)
- 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 experienced one of more adverse events 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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