Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.


Options:
A: GSK2336805 safety parameters : adverse events (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: telemetry (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: absolute values and changes over time of hematology, clinical chemistry, urinalysis (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: vital signs (blood pressure, heart rate) (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 safety parameters: electrocardiogram (ECG) parameters (Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve over the dosing interval AUC(0-tau)) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: maximum observed concentration (Cmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: time to maximum observed concentration (tmax) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: observed concentration at 24h post-dose (C24) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: terminal half-life (t1/2) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: lag time (tlag) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following single dose administration: apparent clearance (CL/F) (Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours); GSK2336805 PK parameters following repeat dose administration:AUC(0-tau) (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Pre-dose (trough) concentration at the end of the dosing interval Ctau (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: Cmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: tmax (Day 7 and Day 14); GSK2336805 PK parameters following repeat dose administration: t1/2, (Day 7 and day 14); GSK2336805 PK parameters following repeat dose administration: CL/F (Day 7 and Day 14); GSK2336805 PK parameters following single dose in HCV infected subjects: AUC(0-infinity) or AUC(0 - tau) (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: Cmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: C24 (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tmax (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: tlag (for 48 hours); GSK2336805 PK parameters following single dose in HCV infected subjects: CL/F (for 48 hours); HCV Ribonucleic acid (RNA) viral load reduction from baseline during the 24hr and post-dosing following a single dose of GSK2336805 in HCV subjects (at baseline, 24 hours, and for 16 days); HCV RNA change from baseline to nadir (maximum change) in HCV subjects (baseline, and for 16 days); Time course of HCV viral load at baseline, after dosing with GSK2336805, and for greater than or equal to 2 weeks after GSK2336805 dosing (Part 3) (baseline and up to 16 days)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 24 weeks)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)

Answer: B