A Real-World Study Evaluating the Safety of Pantoprazole Sodium IV in Infants Aged 1 Month to <1 Year and Patients Aged 1 to <2 Years Using an Electronic Health Records Database from the United States

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BC02) pantoprazole

  pantoprazole

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  14146

Study design details

• Main study objective:
  What are the incidence rates of potential safety events of interest in infants aged 1 month to <1 year and in patients aged 1 to <2 years who were treated with IV pantoprazole in the real-world setting?
• Outcomes:
  The incidence of prespecified outcomes of interest as specified in the protocol in patients with a diagnosis of GERD with or without EE and treated with IV pantoprazole.
• Data analysis plan:
  All statistical analyses will be performed in the two cohorts of interest: infants aged 1 month to <1 year and patients aged 1 to <2 years. Descriptive statistics will be presented to characterize the overall cohort treated with IV pantoprazole and the 3 subgroups defined based on the presence or absence of GERD and EE during the baseline period or on the index date. Incidence rates of outcomes of interest will be estimated as the number of patients with a specific outcome of interest during the follow-up period divided by the total person-time at risk and reported as incidence rate per 1,000 person-years with associated 95% confidence intervals. Incidence rates for all outcomes of interest will be calculated in the overall cohort and in each of the 3 subgroups. Within the overall cohort and in the 3 subgroups, incidence rates will be estimated by duration of IV pantoprazole treatment (<4 days, ≥ 4 days). Two sensitivity analyses will be performed.

Documents

Study report

B1791096 Non-Interventional Study Report Manuscript Signatures 23-Jun-2022.pdf

B1791096 SAP Protonix PASS_V5_01-24-2022_.pdf

Protonix PASS B1791096 Non-Interventional Study Report Abstract 23-Jun-2022_FINAL (1).pdf

Protonix PASS B1791096 Protocol Amendment 1 Clean 02-10-22.pdf

Protonix PASS B1791096_Report_23-Jun-2022_FINAL.pdf