Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.


Options:
A: Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 (Week 52)
B: Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase. (Week 52)
C: Number of Participants With Adverse Events (AE) (Up to 9 years); AE Rates by System Organ Class (SOC) During the Study (Up to 9 years); Number of Participants With Serious Adverse Events (SAE) (Up to 9 years); SAE Rates by SOC During the Study (Up to 9 years); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Hematocrit at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in BUN and Glucose at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points (Baseline and up to 9 years); Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels (Baseline and up to 9 years); Change From Baseline in Bilirubin (Bili) Levels (Baseline and up to 9 years); Change From Baseline in Immunoglobulin G (IgG) Levels (Baseline and up to 9 years); Number of Participants With Immunogenic Response by Year (Up to 9 years); Number of Participants With IgG Values Below the Lower Limit of Normal by Year (Up to 9 years); Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit (Up to 9 years); Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit (Up to 9 years)
D: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 weeks)

Answer: D