Comparison · NCT01339052-sae
Cohorts 1: Surgical Subjects vs Cohorts 2: Non-surgical Subjects: 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. Cohorts 1: Surgical Subjects vs Cohorts 2: Non-surgical Subjects: serious adverse events. Trial comparisons, record NCT01339052-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01339052-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 | 0.152 | 0.583 | wilson | |
| Risk in group 2 | 0.24 | 0.143 | 0.374 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0933 | -0.132 | 0.361 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 0.582 | 3.31 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.452 | 5.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohorts 1: Surgical Subjects than on Cohorts 2: Non-surgical Subjects | 10.7 | 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 | Cohorts 1: Surgical Subjects | Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity. | 5 | 15 | EG000 |
| Group 2 | Cohorts 2: Non-surgical Subjects | Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity. | 12 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
- NCT number
- NCT01339052
- Phases
- PHASE2
- Conditions
- Glioblastoma
- Interventions
- BKM120, Surgery
- Lead sponsor
- L. Nicolas Gonzalez Castro, MD, PhD
- Results first posted
- 2017-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01339052?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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