WRSNSAE

Table Description: Wearable and Sensor Adverse Event Log

1.0 Data Dictionary

ITM_NAME

DSCR_1.0

AEACTDEV

Action taken with study device

AEACTDRT

Action - device returned

AEACTNON

Action/Treatment - None

AEACTOTR

Action - other treatment required

AEACTWDS

Action - perm wearable study discontinue

AEOUT8

AE Primary Outcome v8

AERELDEV

Related to study device

AERELDV

Related to study device-alt version

AESEQ

AE#

AESEVER

Severity

AETERM

Adverse Event

COMM

Comments

HLGTNAME

High Level Group Term

HLT_NAME

High Level Term

LLT_NAME

Low Level Term

PT_CODE

Preferred Term Code

PT_NAME

Preferred Term Name

SAE

SAE

SOCABBR1

System Organ Class 1

STARTDT

Start Date

STARTEST

Start Date Estimation

STOPDT

Stop Date

STOPEST

Stop Date Estimation

UADE

Unexpected Adverse Device Effect

VERBATIM

Verbatim Term

VMEDDRA

MedDRA Version

1.0 Code Book

ITM_NAME

CODE

DECODE_1.0

AEACTDEV

1

Device replaced

AEACTDEV

2

No action taken

AEACTDEV

3

Use interrupted

AEACTDEV

4

Use withdrawn

AEACTDEV

5

Unknown

AEACTDEV

6

Not Applicable

AEOUT8

1

Resolved

AEOUT8

2

Resolved with sequelae

AEOUT8

3

Not resolved

AERELDEV

1

Not related

AERELDEV

2

Possibly related

AERELDEV

3

Probably related

AERELDEV

4

Definitely related

AERELDV

0

Not related

AERELDV

1

Possibly

AERELDV

2

Probably

AERELDV

3

Related

AESEVER

1

mild

AESEVER

2

moderate

AESEVER

3

severe

SAE

0

No

SAE

1

Yes

STARTEST

ACT

Actual date

STARTEST

DAY

Day estimated

STARTEST

MD

Month and Day estimated

STOPEST

ACT

Actual date

STOPEST

DAY

Day estimated

STOPEST

MD

Month and Day estimated

UADE

0

No

UADE

1

Yes