Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (EV-010)

Study type

• Study topic:
  Human medicinal product

  Other
• Study topic, other:
  Long-term safety as observed in real-world clinical practice of injectable for treatment of glabellar lines
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  NI Observational PASS

Study drug and medical condition

• Medicinal product name:
  NUCEIVA
• Study drug International non-proprietary name (INN) or common name:
  BOTULINUM TOXIN TYPE A
• Anatomical Therapeutic Chemical (ATC) code:
  (M03AX01) botulinum toxin

  botulinum toxin
• Medical condition to be studied:
  Skin wrinkling

Population studied

• Short description of the study population:
  Male and female patients below the age of 65 years of age
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  750

Study design details

• Study design:
  750 patients will receive an initial 20U treatment. No additional treatments are required; patients may receive up to 6 treatments over 18 months. Patients will keep a diary of symptoms, side effects or health changes between visits. At the end of 18 months, staff will make final follow up call.
• Main study objective:
  Investigate the long-term safety of NUCEIVA as observed in the real-world clinical practice setting when administered as indicated in the EU/UK for the treatment of glabellar lines over an 18 month observation period.
• Outcomes:
  To provide additional characterisation of the long-term safety of NUCEIVA while ensuring the systematic recording of previous exposure to botulinum toxin A. To collect and assess data on adverse events of particular interest defined as: eye disorders (including eyelid ptosis, brow ptosis, blepharospasm, muscle twitching, blurred vision, diplopia and muscle wasting), and, adverse events potentially suggestive of the distant spread of toxin (including dysphagia and dysphonia).
• Data analysis plan:
  The Safety Population will consist of all patients who receive at least one treatment of NUCEIVA. All analyses will be performed on this safety population unless otherwise presented. Continuous data will be described using descriptive statistics: n, mean, standard deviation, median, minimum and maximum. Categorical data will be summarized as the number and percentage of patients in each category. Epidemiological methods will be used for the analysis of collected data. Analyses will be performed on de-identified data, and will be descriptive in nature. There are no plans for statistical testing or formal comparisons between groups. Results will be displayed in tabular format – i.e. summary statistics, frequency distribution, and incidence rates. No imputations of missing data are planned. All statistical analyses will be performed using SAS Version 9.4 or later.