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Comparison · NCT03732677-242c8b63

Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Proportion of Patients Who Undergo Cystectomy

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. Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Proportion of Patients Who Undergo Cystectomy. Trial comparisons, record NCT03732677-242c8b63. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03732677-242c8b63

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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 10.880.850.905wilson
Risk in group 20.8320.7980.861wilson
Risk difference, group 1 minus group 20.04780.005590.0902newcombe hybrid score
Risk ratio, group 1 over group 21.061.011.11log
Odds ratio, group 1 over group 21.481.052.09log
Number needed to treat, for one more participant with the outcome on Durvalumab + Gemcitabine + Cisplatin than on Gemcitabine + Cisplatin20.911.1179from 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 1Durvalumab + Gemcitabine + Cisplatin
Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
469533OG000
Group 2Gemcitabine + Cisplatin
Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
441530OG001

Outcome

Type
SECONDARY
Title
Proportion of Patients Who Undergo Cystectomy
Description
The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.
Time frame
Up to 6 months
Population
The full analysis set (FAS) Intention to treat included all randomized patients.

Source ClinicalTrials.gov

Trial

Title
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NCT number
NCT03732677
Phases
PHASE3
Conditions
Muscle Invasive Bladder Cancer
Interventions
Durvalumab, Cisplatin, Gemcitabine
Lead sponsor
AstraZeneca
Results first posted
2025-07-03

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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