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Comparison · NCT02152982-sae

Arm II (Temozolomide, Veliparib) vs Arm I (Temozolomide, Placebo): 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. Arm II (Temozolomide, Veliparib) vs Arm I (Temozolomide, Placebo): serious adverse events. Trial comparisons, record NCT02152982-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02152982-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 10.1970.150.255wilson
Risk in group 20.2210.170.281wilson
Risk difference, group 1 minus group 2-0.0234-0.10.0534newcombe hybrid score
Risk ratio, group 1 over group 20.8940.6191.29log
Odds ratio, group 1 over group 20.8680.5451.38log
Number needed to treat, for one fewer participant with a serious adverse event on Arm II (Temozolomide, Veliparib) than on Arm I (Temozolomide, Placebo)42.7from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm II (Temozolomide, Veliparib)
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO \> \> Veliparib: Given PO
43218EG001
Group 2Arm I (Temozolomide, Placebo)
Patients receive temozolomide as in Arm II and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Temozolomide: Given PO
47213EG000

Harm

What it counts
Total, serious adverse events
Time frame
All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years

Source ClinicalTrials.gov

Trial

Title
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT number
NCT02152982
Phases
PHASE2, PHASE3
Conditions
Glioblastoma, Gliosarcoma
Interventions
Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment, Temozolomide, Veliparib
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2023-04-04

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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