| CDE ID | CDE Description | | * 421 | EDRN Participant ID (Go To: 1899) |
| * 1899 | Adverse Event onset date (MM/DD/YYYY): (Go To: 1832) |
| 1832 | Participant initials: (Go To: 423) |
| * 423 | EDRN Protocol ID (Go To: 422) |
| * 422 | EDRN Site ID (Go To: 929) |
| * 929 | EDRN Staff ID of the person who collected the data: (Go To: 5031) |
| * 5031 | Adverse Event (CTCAE v 5.0) (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: 1902) |
| | | Permissible Values (value): | Ongoing (1) |
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| * 1900 | Adverse Event stop date (MM/DD/YYYY): (Go To: 1902) |
| * 1902 | Adverse Event action(s) taken: Check all that apply. (Go To: 1904) |
| | | Permissible Values (value): | None (4) |
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| | | | Permanently Discontinued (7) |
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| | | | Other, specify: (97) (Go To: 5050) |
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| * 5050 | Adverse event action taken (Other, specify): (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) |