Comparison · NCT01217411-sae
Phase 1 Arm I (WBRT + R04929097) vs Phase 1 Arm II (SRS + RO4929097): 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. Phase 1 Arm I (WBRT + R04929097) vs Phase 1 Arm II (SRS + RO4929097): serious adverse events. Trial comparisons, record NCT01217411-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01217411-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 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk in group 2 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.655 | 0.446 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.0803 | 5.54 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0128 | 19.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Phase 1 Arm I (WBRT + R04929097) than on Phase 1 Arm II (SRS + RO4929097) | 6 | 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 | Phase 1 Arm I (WBRT + R04929097) | RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097\*\* (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097\*\* (3 days on/ 4 days off continuous) 2 days prior to SRS | 1 | 3 | EG000 |
| Group 2 | Phase 1 Arm II (SRS + RO4929097) | Patients with =\< 3 brain lesions receive RO4929097 and undergo SRS. For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors \>2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality | 1 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Routine adverse event (AE) monitoring and reporting till 30 days following the last dose of the Investigational Agent, up to 16 weeks total.
Source ClinicalTrials.gov
Trial
- Title
- RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
- NCT number
- NCT01217411
- Phases
- PHASE1, PHASE2
- Conditions
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive, Male Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Recurrent Melanoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
- Interventions
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Stereotactic Radiosurgery, Whole-Brain Radiotherapy
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01217411?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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