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Comparison · NCT00504660-sae

Anaplastic Tumors vs Glioblastoma Multiforme: 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. Anaplastic Tumors vs Glioblastoma Multiforme: serious adverse events. Trial comparisons, record NCT00504660-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00504660-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 10.2580.1370.432wilson
Risk in group 20.3720.2440.521wilson
Risk difference, group 1 minus group 2-0.114-0.3060.102newcombe hybrid score
Risk ratio, group 1 over group 20.6940.341.41log
Odds ratio, group 1 over group 20.5870.2131.62log
Number needed to treat, for one fewer participant with a serious adverse event on Anaplastic Tumors than on Glioblastoma Multiforme8.77from 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 1Anaplastic Tumors
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
831EG000
Group 2Glioblastoma Multiforme
6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
1643EG001

Harm

What it counts
Total, serious adverse events
Time frame
6 years and 3 months

Source ClinicalTrials.gov

Trial

Title
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
NCT number
NCT00504660
Phases
PHASE2
Conditions
Anaplastic Glioma of Brain, Glioblastoma Multiforme, Brain Cancer
Interventions
Capecitabine, Celecoxib (Celebrex), Temozolomide, Lomustine, 6-Thioguanine
Lead sponsor
M.D. Anderson Cancer Center
Results first posted
2012-01-11

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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