A prospective, single arm, non-interventional study to evaluate the extent to which handling errors (HE) lead to Lack of Efficacy (LOE) in patients treated with ELIGARD® in France

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, prospective study

Study drug and medical condition

• Medicinal product name, other:
  Eligard
• Medical condition to be studied:
  Prostate cancer stage II

Population studied

• Short description of the study population:
  Inclusion criteria:; • All male patients ≥ 18 years old on ELIGARD™ treatment (3-month formulation [22.5 mg] or 6-month formulation [45 mg]), with a reported HE associated with the administration of ELIGARD™.; • Patients who were informed of the study and the investigator did not receive any objection by the patient to collect their data.; ; Exclusion criteria:; • Any patient/s correctly re-injected with a new dose of ELIGARD™ shortly after the HE and before a blood sample for serum testosterone was taken.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The primary objective of the study was to assess the LOE following a handling error, as measured by serum testosterone, in a selected sample of French patients with Prostate cancer (PCa) who have been injected with ELIGARD™ following the handling error (HE) or where the HE occurs during the administration of ELIGARD™.
• Outcomes:
  The primary objective was to measure the number and proportion of HE associated with confirmed LOE based on the serum testosterone level after the mishandled ELIGARD™ injection.
• Data analysis plan:
  Demographics and baseline characteristics were to be summarized by dose level for the Safety Analysis Set and Full Analysis Set. Descriptive statistics would have included number of subjects, mean/ SD/min/ median/ max for continuous endpoints, and frequency and percentage for categorical endpoints. Number and proportion of LOE cases among HE cases with a corresponding 95% CI were to be assessed. Descriptive statistics were to be presented in summary tables by dose level and total. AEs were to be coded using MedDRA and graded using NCI CTCAE v 4.03. Number and percentage of AEs, SAEs, AEs leading to discontinuation and AEs related to study drug were to be summarized by System Organ Class, Preferred Term and dose level and total. Number and percentage of AEs by severity were to be summarized. All AEs were to be listed. For quantitative laboratory measurements descriptive statistics were to be used to summarize results and change from baseline by time point for each dose level and total.