| Grade |
Description |
Number of patients |
| 1 |
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
15/16 (94%) |
| 2 |
Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living |
8/16 (50%) |
| 3 |
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living |
1/16 (6%) |
| 4 |
Life-threatening consequences; urgent intervention indicated |
0 |
| 5 |
Death related to AE |
0 |
