Comparison · NCT02101385-sae
Arm A (Genomically Directed Monotherapy) vs Control Arm B (Observation/Standard Therapy): 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. Arm A (Genomically Directed Monotherapy) vs Control Arm B (Observation/Standard Therapy): serious adverse events. Trial comparisons, record NCT02101385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02101385-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 | 0.0282 | 0.00776 | 0.097 | wilson | |
| Risk in group 2 | 0.0164 | 0.00451 | 0.0578 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0118 | -0.0344 | 0.0816 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.72 | 0.247 | 11.9 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.24 | 12.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (Genomically Directed Monotherapy) than on Control Arm B (Observation/Standard Therapy) | 84.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A (Genomically Directed Monotherapy) | Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing: | 2 | 71 | EG000 |
| Group 2 | Control Arm B (Observation/Standard Therapy) | Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician. | 2 | 122 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months.
Source ClinicalTrials.gov
Trial
- Title
- Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
- NCT number
- NCT02101385
- Phases
- PHASE2
- Conditions
- Malignant Neoplasm of Breast, Breast Cancer
- Interventions
- Genomically Directed Monotherapy, Observation/Standard Therapy
- Lead sponsor
- Bryan Schneider, MD
- Results first posted
- 2023-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02101385?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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