A Multi-country, Non-interventional, Retrospective Drug Utilization Study in Haematological Malignancy Patients Treated for Probable or Proven Invasive Aspergillosis (AmBiVor)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VORICONAZOLE

  AMBISOME
• Medical condition to be studied:
  Aspergillus infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The primary objective of the study was to describe demographic, clinical, and treatment patterns/sequences in haematologic malignancy patients treated either with AmBisome or voriconazole as primary treatment for the index proven or probable IA.
• Outcomes:
  Demographic, clinical, and treatment patterns, 42-day overall survival (OS) in haematological malignancy patients with IA treated with either AmBisome or voriconazole as primary treatment, percentage AmBisome- and voriconazole-treated patients that experience adverse events of special interests and any AEs leading to treatment discontinuation or modification, and time to first nephrotoxicy and/or hepatotoxicity during the follow-up period.
• Data analysis plan:
  Descriptive statistics were tabulated for the demographic and clinical characteristics and outcome variables. In all cases, point estimates as well as the corresponding two-sided 95% confidence intervals (CIs) were presented. ; No missing value imputation was performed. ; Treatment sequence was visualized through Sankey diagrams. ; The secondary objective was to estimate the 42-day OS of patients treated with AmBisome and of patients treated with voriconazole. OS and time to first nephrotoxicity and hepatotoxicity were described using Kaplan-Meier methods and reported using descriptive statistics with 95% CIs and survival curves. ;