| ae_event |
|
text |
Adverse Event and relationship to the study procedure |
|
| ae_sae |
|
yesno |
Is this a serious adverse event (SAE)? |
1, Yes ; 0, No |
| sae_criteria |
|
radio |
SAE criteria |
1, Death ; 2, Life threatening ; 3, Hospitalisation ; 4, Medically significant ; 5, Congenital abnormality/birth defect |
| ae_severity |
|
radio |
Severity |
1, Mild ; 2, Moderate ; 3, Severe ; 4, Fatal |
| ae_action |
|
dropdown |
Action |
0, None ; 1, Study interrupted ; 2, Drug therapy given ; 3, Non-drug therapy given |
| ae_action_det |
|
notes |
Action (Further details if required) |
|
| ae_start_date |
|
text |
Start Date |
|
| ae_stop_date |
|
text |
Stop Date |
|
| ae_outcome |
|
radio |
Outcome |
1, Resolved ; 2, Resolved with sequelae ; 3, Ongoing ; 4, Fatal ; 5, Unknown |