Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Brief Summary: This is a long-term continuation study to provide continuing treatment to subjects with SLE.


Options:
A: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 weeks)
B: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Approximately up to 13 years); Adverse Event (AE) Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); SAE Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Erythrocytes at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hematocrit at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hemoglobin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Albumin and Protein at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points (Baseline and approximately up to 13 years)
C: Percentage of Participants With a State of Disease Control at Week 52 (Week 52)
D: 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)

Answer: D