DGBAE¶
Table Description: Digital Biomarker 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 |
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Use withdrawn |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 |
1 |
Actual |
STARTEST |
2 |
Day Est. |
STARTEST |
3 |
Month/Day Est. |
STARTEST |
4 |
Month Est. |
STOPEST |
1 |
Actual |
STOPEST |
2 |
Day Est. |
STOPEST |
3 |
Month/Day Est. |
STOPEST |
4 |
Month Est. |