EVALUATING THE OCCURRENCE OF ADVERSE EVENTS AMONG PEDIATRIC PATIENTS EXPOSED TO INTRAVENOUS LACOSAMIDE (VIMPAT®) USING REAL WORLD DATA

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LACOSAMIDE

Population studied

• Short description of the study population:
  The study population will consist of the following two mutually exclusive cohorts:;  Pediatric patients treated with higher IV LCM doses (including UCB’s defined loading dose), regardless of diagnostic code i.e. patients do not have to have a formal diagnosis of specific types of epilepsy and they may include children with SE caused by other conditions.;  Pediatric patients treated with recommended initial/maintenance IV LCM dose regardless of diagnostic code i.e. patients do not have to have a formal diagnosis of specific types of epilepsy and they may include children with SE caused by other conditions. These two groups are defined by the proposed alternative higher initial dosage (first dose, first treatment in observed episode) and the recommended initial dosage (first dose, first treatment in observed episode) and patients remain in that group thereafter. Switching is not allowed at any time.; Patients will be initially identified using the following study criteria.; ; Inclusion Criteria; • Patients with at least one iv LCM administration (earliest administration defines index date); • At least 1 encounter with iv LCM administered between ages of ≥1 month and <17 years; ; Exclusion Criteria; • No exposure to either oral or iv LCM within the 3 months prior to the index date; o In the case of patients < 90 days of age, no prior LCM ever in the record; A separate cohort for patients < 30 days old is established with the following criteria.; ; Neonates Inclusion Criteria; • Patients with at least one iv LCM administration (earliest administration defines index date); • At least 1 encounter with iv LCM administered before 30 days of age.; ; Neonates exclusion criteria; • No exposure to either oral or iv LCM prior to the index date
• Age groups:
  • Adolescents (12 to < 18 years)
  • Children (2 to < 12 years)
  • Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  681

Study design details

• Main study objective:
  The primary objective of this study is to estimate the incidence of the select medical events of interest, those being the 8 System Organ Classes (SOCs) and 3 Standardized MedDRA Queries (SMQs) listed below, in pediatric patients after treatment with higher intravenous (IV) Lacosamide (LCM) doses, compared to pediatric patients treated with recommended initial/maintenance IV LCM dose.
• Outcomes:
  Incidence rate and ratio of cardiac disorders, general disorders, administration site conditions, injury, poisoning, procedural complications, skin and subcutaneous tissue disorders, drug reactions with eosinophilia, systemic symptoms syndrome, severe cutaneous adverse reactions, hypersensitivity, nervous system disorders, metabolism and nutrition disorders and psychiatric disorders etc. Incidence rate and ratio of atrioventricular block, atrioventricular block complete, atrioventricular block first degree and second degree, arrhythmia, bradyarrhythmia, bradycardia, cardiac fibrillation, cardiac flutter, tachyarrhythmia, atrial fibrillation, atrial flutter, cardiac arrest, torsade de pointes, ventricular arrhythmia, fibrillation and tachyarrhythmia, palpitations, chest pain etc.
• Data analysis plan:
  For the baseline characteristics, mean, standard deviation, median, and quartiles will be used to describe continuous variables, whereas frequencies and percentages will be used to describe categorical variables. The baseline characteristics will include demographic characteristics, number of previous and concomitant Antiepileptic drug, and concomitant medications prescribed prior to the index date, prevalence of comorbidities, preexisting medical events of interest, medical procedures such as EEG, and dosage of intravenous Lacosamide. Incidence rate ratios will be used to compare event rates between groups.