TABLE 2.
Adverse events classified by severity and their relationship to treatmenta
| ADR classification | No. (%) among: |
|||
|---|---|---|---|---|
| Children |
Adults |
|||
| Patients (n = 63) | ADRs (n = 84) | Patients (n = 64) | ADRs (n = 131) | |
| Severity | ||||
| Mild | 47 (74.6) | 60 (71.4) | 54 (84.4) | 101 (77.1) |
| Moderate | 8 (12.7) | 8 (9.5) | 14 (21.9) | 27 (20.6) |
| Severe | 1 (1.6) | 1 (1.2) | 1 (1.6) | 1 (0.8) |
| No data | 11 (17.5) | 15 (17.9) | 1 (1.6) | 2 (1.5) |
| Relationship to treatment | ||||
| None | 5 (7.9) | 10 (11.9) | 2 (3.1) | 2 (1.5) |
| Unlikely | 1 (1.6) | 1 (1.2) | 1 (1.6) | 1 (0.8) |
| Probable | 47 (74.6) | 53 (63.1) | 20 (31.2) | 31 (23.7) |
| Certain | 5 (7.9) | 5 (6) | 51 (79.7) | 95 (72.5) |
| No data | 11 (17.5) | 15 (17.9) | 1 (1.6) | 2 (1.5) |
| Total | 63 (100.0) | 84 (100.0) | 64 (100.0) | 131 (100.0) |
a
Relationship classification was recorded according to the World Health Organization criteria. For each age group, two columns are shown. “Patients” shows the number of patients presenting at least one ADR and its corresponding percentage. “ADRs” shows the observed number of ADRs and its corresponding percentage. Notice that patients could present more than one ADR belonging to different categories (i.e., mild and moderate).