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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