Clinical Evaluation of BW430C in Epilepsy

Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.

Time frame: 8 weeks

Population: Safety Population: all participants enrolled in the study who received at least one dose of study medication

The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?.

Time frame: 8 weeks

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?.

Time frame: Up to Week 8 of the Maintenance Phase (Study Week 14)

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.

Time frame: Up to Week 8 of the Maintenance Phase (Study Week 14)

Population: Safety Population

The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.

Time frame: 8 weeks

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.

Time frame: Up to Week 8 of the Maintenance Phase (Study Week 14)

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.

Time frame: 8 weeks

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.

Time frame: Up to Week 8 of the Maintenance Phase (Study Week 14)

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization.

Time frame: Up to Week 8 of the Maintenance Phase (Study Week 14)

Population: Safety Population. Only those participants who had experienced any rash event were evaluated.

Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges.

Time frame: 8 weeks

Population: Full Analysis Set (FAS) Population: all enrolled participants except those who had no assessments of the main efficacy variable (percent reduction in seizure frequency).

Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 \* 10\^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 \* 10\^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 \* (number of par. with monocyte values outside the normal range) divided by the total number of par.

Time frame: Week 4 and Week 8

Population: Safety Population

Percent change in seizure frequency was calculated as 100 \* (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG.

Time frame: Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)

Population: FAS Population