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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/46262
• EU PAS number:
  EUPAS45389
• Study ID:
  46262
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective cohort study using Optum’s longitudinal electronic health records (EHR) repository from the United States (US). Two separate cohorts, ie, infants aged 1 month to <1 year and patients aged 1 to <2 years who received at least one dispensing of IV pantoprazole during a study period of 01 January 2007 to 31 December 2020 and those enrolled in the database for at least 30 days prior to the date of first dispensing of IV pantoprazole will be identified from the Optum’s longitudinal EHR repository. Within each cohort, 3 subgroups will be identified: (1) patients with ICD-9-CM or ICD-10-CM codes for GERD with EE, (2) patients with ICD-9-CM or ICD-10-CM codes for GERD but without EE, and (3) patients without diagnosis codes for GERD or EE. The research question for this study is: 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? Exposure to IV pantoprazole will be identified from inpatient procedure and drug codes including National Drug Codes (NDC) and Healthcare Common Procedure Coding System (HCPCS) codes. Optum’s longitudinal EHR repository from the US will be used for this study. This dataset contains a combination of structured data (e.g. diagnoses, procedures, prescriptions) and information from unstructured data (e.g. drug rationale, provider notes) from the electronic health record and corresponding claims information for those instances. The claims are verified, adjudicated, adjusted, and de-identified. The database currently encompasses the claims and EHR data of more than 95 million patients with approximately 1.9 million patients aged less than 2 years from 01 January 2007 through 31 December 2020.
• Study status:
  Finalised

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned: 27/05/2021

Actual: 27/05/2021

Study start date

Planned: 04/02/2022

Actual: 04/02/2022

Date of final study report

Planned: 30/06/2022

Actual: 23/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B1791096_PROTONIX PASS PROTOCOL FINAL_12 AUG 2021

Updated protocol

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

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable