Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.


Options:
A: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events. (Day 84)
B: A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score (from baseline (at visit 2) to 16 weeks treatment (at visit 6))
C: Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare (From start of corticosteroid taper to Day 365); Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With Significant AEs of Special Interest (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Urinalysis (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period)
D: Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) (Day 365); Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants (Day 365)

Answer: A