AE¶
Table Description: Adverse Event Log
Detailed notes for this table are included below.
View Source CRFs¶
1.0 CRFs: Click on any PAG_NAME link below to be taken to the CRF used in the PPMI 1.0 Study.
2.0 CRFs: Click on any PAG_NAME link below to be taken to a screenshot of how this eCRF is currently implemented in the PPMI 2.0 Study.
2.0 Data Dictionary¶
Table Constraints: PATNO, SEQNO
ITM_NAME |
DSCR |
ITM_TYPE |
ITM_TYPE_1.0 |
|---|---|---|---|
SEQNO |
Sequence Number |
NUMBER |
|
AETERM |
Adverse Event |
TEXT |
CHAR |
STARTDT |
Start Date |
DATE |
DATE |
STOPDT |
Stop Date |
DATE |
DATE |
AESEVER |
Severity |
NUMBER |
CHAR |
SAE |
SAE |
BOOLEAN |
CHAR |
AERELAT |
Relationship to Study |
NUMBER |
CHAR |
AERELPRO |
Relationship to Study Procedure |
NUMBER |
|
PWDTAE |
Premature Withdrawal due to AE |
BOOLEAN |
CHAR |
AEOUTCOM |
Outcome |
NUMBER |
CHAR |
2.0 Code Book¶
ITM_NAME |
CODE |
DECODE_2.0 |
DECODE_1.0 |
|---|---|---|---|
AEOUTCOM |
1 |
Recovered |
recovered |
AEOUTCOM |
2 |
Under treatment / observation |
under treatment / observation |
AEOUTCOM |
3 |
Change in AE characteristic |
change in AE characteristic |
AEOUTCOM |
4 |
Sequelae |
sequelae |
AEOUTCOM |
5 |
Fatal |
fatal |
AEOUTCOM |
6 |
Unknown |
unknown |
AERELAT |
1 |
Unrelated |
unrelated |
AERELAT |
2 |
Unlikely |
unlikely |
AERELAT |
3 |
Possible |
possible |
AERELAT |
4 |
Probable |
probable |
AERELAT |
5 |
Definite |
definite |
AERELPRO |
1 |
DaTscan |
|
AERELPRO |
2 |
Lumbar Puncture |
|
AERELPRO |
3 |
Skin Biopsy |
|
AERELPRO |
4 |
AV-133 |
|
AERELPRO |
5 |
MK-6240 PET Scan |
|
AESEVER |
1 |
Mild |
mild |
AESEVER |
2 |
Moderate |
moderate |
AESEVER |
3 |
Severe |
severe |
PWDTAE |
0 |
No |
|
PWDTAE |
1 |
Yes |
|
PWDTAE |
Y |
Yes |
|
SAE |
0 |
No |
No |
SAE |
1 |
Yes |
Yes |
Missing Columns¶
ITM_NAME |
DSCR_1.0 |
|---|---|
AEFLUP |
AE Status at final visit |
AESEQ |
AE# |
HLGTNAME |
High Level Group Term |
HLT_NAME |
High Level Term |
INVSTAFF |
Investigator staff code |
LLT_NAME |
Low Level Term |
PT_CODE |
Preferred Term Code |
PT_NAME |
Preferred Term Name |
RELAV133 |
Related to AV-133 |
RELDSCAN |
Related to DaTSCAN |
RELFB |
Related to Florbetaben |
RELLP |
Related to LP |
RELPRCDR |
Related to other study procedure |
RELSKBIO |
Related to Skin Biopsy |
SOCABBR1 |
System Organ Class 1 |
STARTEST |
Start Date Estimation |
STOPEST |
Stop Date Estimation |
VERBATIM |
MedDRA Lookup Term |
VMEDDRA |
MedDRA Version |
Details¶
This table records instances of and updates on adverse events. While this form is assessed at all in-clinic visits, there will be one row in the table per AE event rather than per visit. This means that when the form is completed with no entries or is skipped, no new rows will appear in this table. Updates to an event are recorded in the same row as the original entry. This form should be completed if any adverse events are reported in the Adverse Event Telephone Assessment (TEL for 2.0 participants and <AVTEL for Early Imaging participants). While the conceptual content of this table has not changed from PPMI 1.0 to 2.0, several schema changes and future updates are described below.
SEQNO
This variable was added to replace the 1.0 variable AESEQ. This was done to standardize the sequence number variables in all log forms which in PPMI 1.0 had included a mix of variables named SEQNO and ones named per-table. Sequence numbers in PPMI 2.0 are not manually recorded in the log but are instead derived in post-processing. This transformation is standard for all log forms.
AERELPRO
This variable was added to replace the set of 1.0 variables: RELDSCAN, RELLP, RELPRCDR, RELAV133, RELFB, RELSKBIO. This change was made on the basis of the decision that a single AE should not be related to multiple study procedures. The options “Related to Florbetaben” and “Related to other study procedure” have been removed. The MK-6240 PET SCAN option was added to the AE log as an option for this variable in February of 2021 in anticipation of the upcoming Tau substudy.
Date Estimation
STARTEST and STOPEST have been removed from this table following a study-wide decision to remove indications of date estimation from all CRFs.
Future State
The six PPMI 1.0 variables that recorded an AE’s relation to the study will be combined into the single PPMI 2.0 AERELPRO variable. There are only 10 instances in 1.0 where multiple relations had been selected and they will be handled in a to-be-determined manner.
The 7 variables related to MedDRA coding that are currently marked as DERIVED in the Missing Variables table: LLT_NAME, PT_CODE, PT_NAME, HLT_NAME, HLGTNAME, SOCABBR1, VMEDDRA will be derived using the MedDRA database.