Incidence rates of adverse events of special interest: Guillain-Barré syndrome and Bell’s palsy

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Guillain-Barre syndrome

  Bell's palsy

Population studied

• Short description of the study population:
  The study population consisted of patients registered with GPs in the UK who contributed to the IMRD UK databases from 2017 to 2019, who had at least 365 days of observation prior to start of the yearly period and were observable during at least one of day of 2017, 2018 or 2019.
• 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)
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  1. To obtain yearly incidence rates for Guillain-Barré syndrome and Bell’s palsy between 2017 and 2019 as pre-COVID-19 event rates in IRMS UK and IMS FR/DE, 2. To stratify the incidence rates for Guillain-Barré syndrome and Bell’s palsy between 2017 and 2019 in the UK, FR and DE by year, gender and age group.
• Data analysis plan:
  The incidence rate is the calculated as the number of events divided by the total follow up time.