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Comparison · NCT00104676-sae

Arm I vs Arm II: 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 I vs Arm II: serious adverse events. Trial comparisons, record NCT00104676-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00104676-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 10.3780.2880.476wilson
Risk in group 20.5520.4570.644wilson
Risk difference, group 1 minus group 2-0.175-0.303-0.0375newcombe hybrid score
Risk ratio, group 1 over group 20.6830.5030.929log
Odds ratio, group 1 over group 20.4920.280.861log
Number needed to treat, for one fewer participant with a serious adverse event on Arm I than on Arm II5.723.326.7from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm I
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered
3798EG000
Group 2Arm II
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.~bleomycin sulfate: At least one course administered~cisplatin: At least one course administered~etoposide: At least one course administered~ifosfamide: Given in a dose-dense sequential fashion~oxaliplatin: Given in a dose-dense sequential fashion~paclitaxel: Given in a dose-dense sequential fashion
58105EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
NCT number
NCT00104676
Phases
PHASE3
Conditions
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Interventions
bleomycin sulfate, cisplatin, etoposide, ifosfamide, oxaliplatin, paclitaxel
Lead sponsor
UNICANCER
Results first posted
2021-06-07

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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