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
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational, population-based study
Study drug and medical condition

Name of medicine

VFEND

Medical condition to be studied

Candida sepsis
Aspergillus infection
Population studied

Short description of the study population

The study included patients with at least one filled prescription of voriconazole in the Swedish Prescribed Drug Register. The patients were identified from the population-based Swedish National Registers from 2006 to 2021 for the study period of 1 January 2006 to 31 December 2017.
Eligibility criteria:
• Patients with at least one filled prescription of voriconazole in the Swedish Prescribed Drug Register will be included in this study.
• Note: Although the study will include patients with at least one filled prescription of voriconazole to be inclusive for safety reporting purposes, the analysis for the study objective will mainly focus on patients treated with long-term voriconazole use.

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • 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

3660
Study design details

Main study objective

To estimate the incidence rate of hepatic disorders, phototoxicity, SCC of the skin, visual disorders and periostitis among adult and paediatric patients receiving voriconazole, particularly with long-term use.

Outcomes

The primary study outcomes are hepatic disorders, phototoxicity, SCC of the skin, periostitis and visual disorders. Secondary outcomes include gastrointestinal disorders, nausea, vomiting, abdominal pain, abdominal discomfort, diarrhea, dyspepsia, flatulence, non-infective gastroenteritis, and death.

Data analysis plan

Descriptive statistics will be performed to describe patient demographic and clinical characteristics.Demographic characteristics include age, sex, geographic region, county of birth, and occupation.Clinical characteristics include co-morbid/underlying conditions, use of voriconazole for approved or non-approved indications, and concomitant medications.Main outcomes (safety events) will be analyzed using a piecewise exponential model that allows separate estimation of the hazard within voriconazole treatment intervals (≤3 months, >3 to ≤6 months, >6 to ≤9 months, >9 to ≤12 months, and > 12 month).The following results will be presented by safety event: • Incidence rates and cumulative incidence rates with corresponding 95% CI, • Number of new events reported during follow-up, • Cumulative person-time at risk, and • Sub-group analyses of incidence rates across various demographic and baseline characteristics(i.e. age group, co-morbid/underlying conditions)when enough data exist