Real-world Evidence on Diagnosed Gastroparesis in Europe: Multi-database Observational Epidemiological Study (TAK-906-5003)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Impaired gastric emptying

Population studied

• 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:
  9000000

Study design details

• Main study objective:
  To assess the incidence and prevalence of gastroparesis in the populations in countries of interest and to describe patients with gastroparesis in terms of their characteristics incl. socio-demographic characteristics, etiologic factors, clinical characteristics, diagnostic and treatment practices.
• Outcomes:
  The primary outcome for the analyses of incidence and prevalence will be gastroparesis, as identified using a case definition based on information on diagnoses and other clinical records, records of conducted tests and test results, procedures, and recorded pharmacological and non-pharmacological treatment.
• Data analysis plan:
  Cases of gastroparesis will be identified using a case definition based on information on diagnoses and other clinical records, records of conducted tests and test results, procedures, and recorded pharmacological and non-pharmacological treatment. ; For the analyses of occurrence of gastroparesis, the incidence rate and prevalence with 95% confidence intervals will be estimated. Incidence rates and prevalence will be reported overall and stratified by age group, sex, and calendar year. ; For the analyses of characteristics of cases of gastroparesis, standard descriptive statistical method measures will be used, including mean, standard deviation, median, and distribution quartiles, number of non-missing observations, number of participants with missing data. ; For categorical variables, the proportion and frequency of patients in each category level will be reported.