Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Brief Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.


Options:
A: Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm (Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)); Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm (Baseline until death due to any cause (up to approximately 73 months)); Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm (Baseline until death due to any cause (up to approximately 73 months))
B: Objective Response Rate Per BIRC Assessment (From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)); ORR Per BIRC Assessment by PD-L1 Expression Level (From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)); Time to Response (TTR) (From first dosing date to the date of the first confirmed response (up to approximately 14 months)); Duration of Response (DOR) (From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months))
C: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); Overall Survival (OS) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months))
D: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)

Answer: A