Comparison · NCT03909971-sae
Cohort 1 vs Cohort 2: serious adverse events
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. Cohort 1 vs Cohort 2: serious adverse events. Trial comparisons, record NCT03909971-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03909971-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 | 0.343 | 0.241 | 0.463 | wilson | |
| Risk in group 2 | 0.381 | 0.25 | 0.532 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0377 | -0.22 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.901 | 0.542 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.849 | 0.381 | 1.89 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1 than on Cohort 2 | 26.5 | 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 | Cohort 1 | Participants whose disease had progressed after crizotinib as the only ALK inhibitor were enrolled in Cohort 1 to receive lorlatinib 100 mg orally QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, or the study is terminated by the sponsor, whichever comes first. Each cycle duration was 21 days. | 23 | 67 | EG000 |
| Group 2 | Cohort 2 | Participants whose disease had progressed after one ALK inhibitor treatment other than crizotinib, with or without prior crizotinib were enrolled in Cohort 2 to receive lorlatinib 100 mg QD continuously until confirmed disease progression by ICR (unless clinical benefit is still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, or the study is terminated by the sponsor, whichever comes first. Each cycle duration was 21 days. | 16 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China
- NCT number
- NCT03909971
- Phases
- PHASE2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Lorlatinib
- Lead sponsor
- Pfizer
- Results first posted
- 2021-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03909971?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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