Adverse Events Log

data(adverse)

Format

A data frame with 816 rows and 82 variables

Details

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

Examples

# NOT RUN {
\donotrun{
describe(adverse)
}
# }