Comparison · NCT03425643-fe5f902a
NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo: Number of Participants Who Experience Perioperative Complications
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. NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo: Number of Participants Who Experience Perioperative Complications. Trial comparisons, record NCT03425643-fe5f902a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03425643-fe5f902a
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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 | 0.717 | 0.666 | 0.763 | wilson | |
| Risk in group 2 | 0.722 | 0.671 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00547 | -0.0746 | 0.0639 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.992 | 0.901 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.973 | 0.69 | 1.37 | log | |
| Number needed to treat, for one fewer participant with the outcome on NAC + Neoadjuvant/Adjuvant Pembrolizumab than on NAC + Neoadjuvant/Adjuvant Placebo | 183 | 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 | NAC + Neoadjuvant/Adjuvant Pembrolizumab | Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\].~Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\]. | 233 | 325 | OG000 |
| Group 2 | NAC + Neoadjuvant/Adjuvant Placebo | Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\].~Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\]. | 229 | 317 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experience Perioperative Complications
- Description
Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be assessed.
- Time frame
- Up to approximately 51 weeks following surgery
- Population
- The analysis population consisted of all randomized participants who received at least one dose of neoadjuvant study treatment and also undergo on-study surgery.
Source ClinicalTrials.gov
Trial
- Title
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
- NCT number
- NCT03425643
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Pembrolizumab, Placebo, Cisplatin, Gemcitabine, Pemetrexed
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2024-09-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03425643?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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