Comparison · NCT03207347-sae
Cohort A vs Cohort B: 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 A vs Cohort B: serious adverse events. Trial comparisons, record NCT03207347-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03207347-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 | 0.348 | 0.188 | 0.551 | wilson | |
| Risk in group 2 | 0.5 | 0.268 | 0.732 | wilson | |
| Risk difference, group 1 minus group 2 | -0.152 | -0.434 | 0.156 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.696 | 0.323 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.533 | 0.138 | 2.07 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort A than on Cohort B | 6.57 | 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 A | This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma.~Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle. | 8 | 23 | EG000 |
| Group 2 | Cohort B | This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate).~Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle. | 7 | 14 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events and adverse events of special interest were collected, at a minimum, from the time of informed consent until 90 days after the last dose of niraparib. All other adverse events were collected, at a minimum, from the time of informed consent until 30 days after the last dose of niraparib. Adverse events were collected for a maximum of 911 days.
Source ClinicalTrials.gov
Trial
- Title
- A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
- NCT number
- NCT03207347
- Phases
- PHASE2
- Conditions
- Mesothelioma, Uveal Melanoma, Renal Cell Carcinoma, Cholangiocarcinoma
- Interventions
- Niraparib
- Lead sponsor
- University of Florida
- Results first posted
- 2023-09-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03207347?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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