Adverse Events Log
A data frame with 934 rows and 82 variables
A dataset with variables as follows:
AENUMBER N NA Adverse event number
AEHEVNT T NA Event diagnosis (or medical term if diagnosis is unknown)
AEHCOMM T NA Provide a full description of event:
AECHANGE N NA Is this event a:
AEPENUM N NA Initial Health Assessment Condition Number:
AECOMPOUND N NA Is this event part of a compound event?
AERELAES T NA If yes, provide related adverse event number(s):
AEHONSDT D YYYY-MM-DD Event onset date
AEOUTCOME N NA Event outcome
AEUNK T NA If Unknown, please clarify reason outcome is unknown:
AEHCSDT D YYYY-MM-DD Event cease date
AEHDTHDT D YYYY-MM-DD Date of death
AEHDCAUS T NA Cause of death:
AEHCHRON N NA Initial Chronicity
AEHSEVR N NA Initial Severity
AERELAD N NA Related to symptoms associated with the development of early stage AD or progression of AD
AERELCM N NA Related to concomitant therapy
AERELFLRBTBN N NA Related to Florbetaben tracer
AERELFLRBPR N NA Related to Florbetapir tracer
AEHIMG N NA Related to PET/MRI imaging procedure
AERELTAU N NA Related to AV-1451 (Tau) tracer
AEHLUMB N NA Related to lumbar puncture
AERELATESP N NA Related to other study procedure(s)
AEHCMEDS N NA Was treatment (medication) for AE required?
AESERIOUS N NA Was event serious at any time during the trial?
AESERDATE D YYYY-MM-DD Date event became serious:
AEDTSITE D YYYY-MM-DD Date site became aware that the event is serious:
SAELIFE N NA Is this an SAE because event was life-threatening?
SAEHOSPIT N NA Is this an SAE because it lead to hospitalization?
SAEPROLONG N NA Is this an SAE because it lead to prolongation of hospitalization?
SAEDEATH N NA Is this an SAE because it lead to death?
SAECONGEN N NA Is this an SAE because it lead to a congenital anomaly or birth defect?
SAEDISAB N NA Is this an SAE because it caused persistent or significant disability/incapacity?
SAEOTHER N NA Is this an SAE because it lead to another medically important condition?
AEOTHERHX T NA SAE Narrative: Relevant medical history, Relationship of this event to other events, and all other applicable information
AECHANGE1 N NA Is there a change to report?
AEDATE1 D YYYY-MM-DD Change 1. Date
AESEV1 N NA Change 1: Severity
AECHRON1 N NA Change 1: Chronicity
AECHANGE2 N NA Is there a 2nd change to report?
AEDATE2 D YYYY-MM-DD Change 2. Date
AESEV2 N NA Change 2: Severity
AECHRON2 N NA Change 2: Chronicity
AECHANGE3 N NA Is there a 3rd change to report?
AEDATE3 D YYYY-MM-DD Change 3. Date
AESEV3 N NA Change 3: Severity
AECHRON3 N NA Change 3: Chronicity
AECHANGE4 N NA Is there a 4th change to report?
AEDATE4 D YYYY-MM-DD Change 4. Date
AESEV4 N NA Change 4: Severity
AECHRON4 N NA Change 4: Chronicity
AECHANGE5 N NA Is there a 5th change to report?
AEDATE5 D YYYY-MM-DD Change 5. Date
AESEV5 N NA Change 5: Severity
AECHRON5 N NA Change 5: Chronicity
AECHANGE6 N NA Is there a 6th change to report?
AEDATE6 D YYYY-MM-DD Change 6. Date
AESEV6 N NA Change 6: Severity
AECHRON6 N NA Change 6: Chronicity
AECHANGE7 N NA Is there a 7th change to report?
AEDATE7 D YYYY-MM-DD Change 7. Date
AESEV7 N NA Change 7: Severity
AECHRON7 N NA Change 7: Chronicity
AECHANGE8 N NA Is there a 8th change to report?
AEDATE8 D YYYY-MM-DD Change 8. Date
AESEV8 N NA Change 8: Severity
AECHRON8 N NA Change 8: Chronicity
AECHANGE9 N NA Is there a 9th change to report?
AEDATE9 D YYYY-MM-DD Change 9. Date
AESEV9 N NA Change 9: Severity
AECHRON9 N NA Change 9: Chronicity
AECHANGE10 N NA Is there a 10th change to report?
AEDATE10 D YYYY-MM-DD Change 10. Date
AESEV10 N NA Change 10: Severity
AECHRON10 N NA Change 10: Chronicity
RID N Participant roster ID
SITEID N Site ID
VISCODE T Visit code
USERDATE S Date record created
USERDATE2 S Date record last updated