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Use withdrawn  | 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  |