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 in the United States
Brief Summary: This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.


Options:
A: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 weeks)
B: 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)
C: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Up to Week 440); AE Rates by System Organ Class (SOC) During the Study (Up Week 440); SAE Rates by System Organ Class (SOC) During the Study (Up to Week 440); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Up to Week 440); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points (Up to Week 440); Change From Baseline in Erythrocytes at the Indicated Time Points (Up to Week 440); Change From Baseline in Hematocrit at the Indicated Time Points (Up to Week 440); Change From Baseline in Hemoglobin at the Indicated Time Points (Up to Week 440); Change From Baseline in Albumin and Protein at the Indicated Time Points (Up to Week 440); Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine Clearance at the Indicated Time Points (Up to Week 440); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Up to Week 440); Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points (Up to Week 432); Number of Participants With the Indicated Immunogenic Response (Up to Week 440); Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. (Up to Week 432); Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. (Up to Week 440); Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. (Up to Week 440)
D: Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 (Week 52)

Answer: C