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Comparison · NCT00525525-sae

Efficacy Group vs Safety Lead-in 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

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ConductScience Library. Efficacy Group vs Safety Lead-in Group: serious adverse events. Trial comparisons, record NCT00525525-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00525525-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.5420.4170.663wilson
Risk in group 20.4670.2480.699wilson
Risk difference, group 1 minus group 20.0757-0.1880.325newcombe hybrid score
Risk ratio, group 1 over group 21.160.6452.1log
Odds ratio, group 1 over group 21.350.4354.22log
Number needed to harm, for one more participant with a serious adverse event on Efficacy Group than on Safety Lead-in Group13.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Efficacy Group
Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
3259EG000
Group 2Safety Lead-in GroupA safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.715EG001

Harm

What it counts
Total, serious adverse events
Time frame
Duration of study treatment (up to 24 months after initial radiation)

Source ClinicalTrials.gov

Trial

Title
Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma
NCT number
NCT00525525
Phases
PHASE2
Conditions
Glioblastoma, Gliosarcoma
Interventions
Bevacizumab, Tarceva, Temozolomide
Lead sponsor
University of California, San Francisco
Results first posted
2014-11-14

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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