Evaluation of the Safety and Effectiveness of BOTOX® Injection 50 Units (ClostridiumBotulinum Toxin Type A) for the Treatment of Patients with Moderate to Severe Lateral Canthal Lines (Crow’s Feet Lines) With or Without Simultaneous Glabellar Lines Treatment:A Postmarketing Surveillance Study in Korea

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational postmarketing surveillance (PMS)

Study drug and medical condition

• Name of medicine, other:
  Botox

Population studied

• Short description of the study population:
  Adult Korean patients, 18 to 75 years of age, inclusive, treated with BOTOX for moderate to severe crow’s feet lines only or for crow’s feet lines and glabellar lines simultaneously according to the approved label.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The purpose of this postmarketing surveillance (PMS) study is to evaluate the safety and effectiveness of BOTOX for the treatment of patients with moderate to severe crow’s feet lines through active surveillance under routine clinical practice
• Outcomes:
  All adverse events that occur during the index BOTOX administration and/or during the follow-up period after BOTOX administration, Investigators rating of improvement in appearance of crow's feet lines (improved, unchanged, or worsened) during follow-up visits. Patient's assessment of the change in the appearance of crow’s feet lines compared with the appearance before the index BOTOX treatment (very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse)
• Data analysis plan:
  Categorical variables (eg, gender) will be summarized by the number and percentage of patients in each category. Any missing category included in the CRF or generated from data collection will be treated as an independent category without imputation. For describing the incidence of adverse events, the frequency, patient-time incidence rate, and 95% CI for the incidence measures will be displayed. Unless otherwise specified, the 95% CI of the proportions will be calculated using the exact method, and the 95% CI of the incidence rates will be constructed assuming the frequency of a particular event in a given period of time follows a Poisson distribution. Continuous variables (eg, age) will be summarized using descriptive statistics (number of non-missing values, mean, standard deviation, median, minimum, and maximum values). Additional exploratory descriptive and inferential analyses of the data will be conducted as deemed appropriate.

Documents

Study results

BOTOX_CFL_Re-RPT_dV1.0_Eng_(20180502)_Redacted_29_Jun_2018