Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

Table 1

Data collection set schema details for the PMSST use case.

Scheme item description	Data Elements of the Schema Item	Corresponding SDTM data element name	MedDRA code for MH.MHPTCD
Sex	Sex	DM.SEX
Date of acute Coronary syndrome (ACS) event	(i) ACS event; (ii) Start date of ACS event	(i) MH.MHPTCD; (ii) MH.MHSTDTC	10051592
Date of acute myocardial infarction	(i) Acute myocardial infarction; (ii) Start date of acute myocardial infarction	(i) MH.MHPTCD; (ii) MH.MHSTDTC	10000891
Date of unstable angina	(i) Unstable angina pectoris; (ii) Start date of unstable angina pectoris	(i) MH.MHPTCD; (ii) MH.MHSTDTC	10002388
Had a congestive heart failure (CHF) before start of ACS (Y/N)	(i) Congestive heart failure; (ii) Congestive heart failure time indicator	(i) MH.MHPTCD; (ii) MH.MHSTDTC	10007559
Had a CHF after start of ACS (Y/N)	(i) Congestive heart failure; (ii) Congestive heart failure time indicator	(i) MH.MHPTCD; (ii) MH.MHSTDTC	10007559