Comparison · NCT01639001-sae
Crizotinib vs Chemotherapy: 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. Crizotinib vs Chemotherapy: serious adverse events. Trial comparisons, record NCT01639001-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01639001-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 | 0.442 | 0.351 | 0.538 | wilson | |
| Risk in group 2 | 0.129 | 0.0768 | 0.208 | wilson | |
| Risk difference, group 1 minus group 2 | 0.314 | 0.192 | 0.423 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.44 | 1.98 | 5.96 | log | |
| Odds ratio, group 1 over group 2 | 5.37 | 2.67 | 10.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Crizotinib than on Chemotherapy | 3.19 | 2.37 | 5.2 | 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 | Crizotinib | Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks. | 46 | 104 | EG000 |
| Group 2 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve \[AUC\] of 5 or 6 mg\*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. | 13 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks).
Source ClinicalTrials.gov
Trial
- Title
- A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
- NCT number
- NCT01639001
- Phases
- PHASE3
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Interventions
- Crizotinib, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin
- Lead sponsor
- Pfizer
- Results first posted
- 2017-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01639001?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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