Comparison · NCT01227434-sae
Surgical Group vs Non-surgical Group: 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. Surgical Group vs Non-surgical Group: serious adverse events. Trial comparisons, record NCT01227434-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01227434-sae
On this page
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 | 0.833 | 0.436 | 0.97 | wilson | |
| Risk in group 2 | 0.25 | 0.102 | 0.495 | wilson | |
| Risk difference, group 1 minus group 2 | 0.583 | 0.117 | 0.785 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.33 | 1.33 | 8.37 | log | |
| Odds ratio, group 1 over group 2 | 15 | 1.32 | 170 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Surgical Group than on Non-surgical Group | 1.71 | 1.27 | 8.55 | from the risk difference interval |
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 | Surgical Group | PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles. | 5 | 6 | EG000 |
| Group 2 | Non-surgical Group | Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles. | 4 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 3 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma
- NCT number
- NCT01227434
- Phases
- PHASE2
- Conditions
- Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma
- Interventions
- PD 0332991 (pre-surgery), PD 0332991, Resection as clinical care
- Lead sponsor
- University of California, San Francisco
- Results first posted
- 2015-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01227434?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01227434-sae