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Table 2 Consensus list of top 14 form domains in order of frequency of occurrence. This list also includes the SDTM domain abbreviation if available and in how many trials the domain is used, the number of total forms and the containing data elements

From: Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

Form domain SDTM domain In no. of trials No. of forms No. of data elements
 Medical History MH 23 85 1336
 Adverse Event AE 23 78 2733
 Laboratory test results LB 10 75 1643
 Disposition DS 19 74 653
 Vital Signs VS 23 56 974
 Concomitant Medications CM 22 52 1334
 Questionnaire/Patient reported outcome QS 16 35 1122
 Demographics DM 23 34 371
 ECG EG 12 30 436
 Disease Characteristics (ZC) 12 25 190
 Substance Use SU 14 22 246
 Surgery - 9 20 80
 Physical Examination PE 5 10 33
 Tumor response RS 1 7 27