Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02
Brief Summary: This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.


Options:
A: 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)
B: 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)
C: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)
D: Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 (Week 52)

Answer: A