Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Brief Summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.


Options:
A: Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 (Baseline, 16 hours post-dose on Day 28); Number of Participants With Change From Baseline in Physical Examinations (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 (Baseline, 16 hours post-dose on Day 28); Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 (Baseline, 16 hours post-dose on Day 28); Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Number of Adverse Events (AEs) According to Severity (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Number of Participants With Laboratory Abnormalities (SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37); Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 (Baseline, 24 hours post-dose on Day 1); Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 (Baseline, 16 hours post-dose on Day 10); Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 (Baseline, 16 hours post-dose on Day 28); Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1); Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 (pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1); Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 (pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1)
B: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
C: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
D: Long-term Safety and Tolerability of Secukinumab (Week 268)

Answer: D