BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.

Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).

Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy

Percentage of participants with potentially clinically significant hematology laboratory abnormalities.

Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days

Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy

Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3\*ULN) concurrent with elevated total bilirubin was also evaluated.

Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days

Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy

Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.