Comparison · NCT03565991-sae
Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): 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. Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): serious adverse events. Trial comparisons, record NCT03565991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03565991-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 | 0.314 | 0.247 | 0.39 | wilson | |
| Risk in group 2 | 0.171 | 0.0853 | 0.313 | wilson | |
| Risk difference, group 1 minus group 2 | 0.144 | -0.0132 | 0.258 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.84 | 0.903 | 3.76 | log | |
| Odds ratio, group 1 over group 2 | 2.23 | 0.924 | 5.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1 (BRCA 1/2 Defect) than on Cohort 2 (ATM Defect) | 6.96 | 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 (BRCA 1/2 Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes were enrolled in Cohort 1. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. | 50 | 159 | EG000 |
| Group 2 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. | 7 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately.
Source ClinicalTrials.gov
Trial
- Title
- Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
- NCT number
- NCT03565991
- Phases
- PHASE2
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Genes, BRCA 1
- Interventions
- Avelumab, Talazoparib
- Lead sponsor
- Pfizer
- Results first posted
- 2023-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03565991?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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