Comparison · NCT02584634-sae
Group A: Avelumab + Crizotinib vs Group B: Avelumab + Lorlatinib: serious adverse events
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. Group A: Avelumab + Crizotinib vs Group B: Avelumab + Lorlatinib: serious adverse events. Trial comparisons, record NCT02584634-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02584634-sae
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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 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk in group 2 | 0.677 | 0.501 | 0.814 | wilson | |
| Risk difference, group 1 minus group 2 | -0.261 | -0.523 | 0.0564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.615 | 0.302 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.34 | 0.0862 | 1.34 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group A: Avelumab + Crizotinib than on Group B: Avelumab + Lorlatinib | 3.84 | 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 | Group A: Avelumab + Crizotinib | Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule. | 5 | 12 | EG000 |
| Group 2 | Group B: Avelumab + Lorlatinib | Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule. | 21 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
- NCT number
- NCT02584634
- Phases
- PHASE1, PHASE2
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Avelumab, PF-06463922, Crizotinib
- Lead sponsor
- Pfizer
- Results first posted
- 2022-02-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02584634?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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