BioMed Research International / 2015 / Article / Tab 1

Research Article

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 descriptionData Elements of the Schema ItemCorresponding SDTM data element nameMedDRA code for MH.MHPTCD

SexSexDM.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

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