Form:GLNE 007 Adverse Event v9.0


CDE IDCDE Description
* 421EDRN Participant ID (Go To: 1899)
* 1899Adverse Event onset date (MM/DD/YYYY): (Go To: 423)
* 423EDRN Protocol ID (Go To: 422)
* 422EDRN Site ID (Go To: 929)
* 929EDRN Staff ID of the person who collected the data: (Go To: 4644)
* 4644Age at date of visit, procedure, or data abstraction: (Go To: 1897)
* 1897Adverse Event: (Go To: 1898)
* 1898Is this a Serious AE? (Go To: 1901)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown (99)
* 1901Adverse Event Status: (Go To: 1902)
 
Permissible Values (value):Ongoing (1)
 
 Ended (2) (Go To: 1900)
 
 Unknown (99)
* 1900Adverse Event stop date (MM/DD/YYYY): (Go To: 1902)
* 1902Adverse Event action(s) taken: Check all that apply. (Go To: 1904)
 
Permissible Values (value):None (4)
 
 Administration Hold (6)
 
 Permanently Discontinued (7)
 
 Unknown (99)
* 1904Adverse Event relationship to study treatment. (Go To: 1905)
 
Permissible Values (value):Related (1)
 
 Not Related (2)
 
 Unknown (99)
* 1905Adverse Event Grade: (Go To: 1097)
   1097Comments (do not include any participant identifiers) (Go To: End of Form)