Rapid Data Analysis – Ceftriaxone and hepatic events

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CEFTRIAXONE
• Medical condition to be studied:
  Liver disorder
• Additional medical condition(s):
  Hepatic disorder (NOS), toxic liver disease (ICD 10 code K71), Hepatic failure not elsewhere classified (ICD 10 code K72), nonspecific reactive hepatitis (ICD 10 code K75.2), granulomatous hepatitis not elsewhere classified (ICD 10 code K75.3), unspecified and other specified inflammatory liver disease (ICD 10 codes K75.8-K75.9), unspecified and other specified diseases of liver (ICD 10 codes K76.8-K76.9)

Population studied

• Short description of the study population:
  All patients in IMS® Disease Analyzer France and Germany with a ceftriaxone prescription and least 365 days of observation prior to their first ceftriaxone prescription.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  • What is the incidence of potential hepatotoxic events within 30 days after treatment initiation of ceftriaxone in patients with and patients without a prior history of liver disease or other hepatic risk factors? • What is the incidence of potential hepatotoxic events within 30 days after treatment initiation of ceftriaxone by gender, age group, indication, and dose?
• Outcomes:
  • toxic liver disease (ICD 10 code K71) • hepatic failure not elsewhere classified (ICD 10 code K72) • nonspecific reactive hepatitis (ICD 10 code K75.2) • granulomatous hepatitis not elsewhere classified (ICD 10 code K75.3) • unspecified and other specified inflammatory liver disease (ICD 10 codes K75.8-K75.9) • unspecified and other specified diseases of liver (ICD 10 codes K76.8-K76.9)
• Data analysis plan:
  The incidence rate of hepatic outcome events during a maximum of 30 days of follow-up after each ceftriaxone prescription has been calculated per 1000 person-years of follow-up in each subgroup and stratum. Only the first hepatic outcome event after start of ceftriaxone and the time until the first hepatic outcome event is considered. Separate results are presented for some specific risk factors. Results are also stratified by gender, age group at first ceftriaxone prescription (0-17 years, 18-49 years, 50-69 years and ≥70 years), indication at first ceftriaxone prescription (upper respiratory tract infection, lower respiratory tract infection, ear infection, urinary tract infection, genital infection, prostate infection, testicular infection, gastrointestinal infection, skin/soft tissue infection, bone infection, borrelia (Lyme disease), central nervous system infection, other infection), and total dose at first ceftriaxone prescription.