| CDE ID | CDE Description | | * 421 | EDRN Participant ID (Go To: 1899) |
| * 1899 | Adverse Event onset date (MM/DD/YYYY): (Go To: 422) |
| * 423 | EDRN Protocol ID (Go To: 929) |
| * 422 | EDRN Site ID (Go To: 423) |
| * 929 | EDRN Staff ID of the person who collected the data: (Go To: 4918) |
| * 4918 | Date when site became aware of this adverse event (Go To: 1897) |
| * 1897 | Adverse Event: (Go To: 1898) |
| * 1898 | Is this a Serious AE? (Go To: 1901) |
| | | Permissible Values (value): | No (0) |
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| * 1901 | Adverse Event Status: (Go To: 1904) |
| | | Permissible Values (value): | Ongoing (1) |
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| * 1900 | Adverse Event stop date (MM/DD/YYYY): (Go To: 1904) |
| * 1904 | Adverse Event relationship to study treatment. (Go To: 1905) |
| | | Permissible Values (value): | Related (1) |
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| * 1905 | Adverse Event Grade: (Go To: 1097) |
| 1097 | Comments (do not include any participant identifiers) (Go To: End of Form) |