Table 5.
Distribution of adverse drug events (AEs) categorized according to the system organ classes (SOCs) and involving aripiprazole as a suspected drug, stratified for pediatric patients aged 3–11 and 12–17 years recognized in EudraVigilance spontaneous reporting system from 2016 to 2018.
| System organ class | Aripiprazole N (%) | p | ||
|---|---|---|---|---|
| TOT | 3–11 years | 12–17 years | ||
| Psychiatric disorders | 606 (20.2) | 191 (18.3) | 415 (21.3) | >0.05 |
| Nervous system disorders | 476 (15.9) | 178 (17.0) | 298 (15.3) | >0.05 |
| Injury, poisoning and procedural complications | 446 (14.9) | 152 (14.6) | 294 (15.1) | >0.05 |
| General disorders and administration site conditions | 317 (10.6) | 106 (10.2) | 211 (10.8) | >0.05 |
| Investigation | 188 (6.3) | 33 (3.2) | 155 (8.0) | >0.05 |
| Metabolism and nutrition disorders | 180 (6.0) | 106 (10.2) | 74 (3.8) | <0.05 |
| Gastrointestinal disorders | 146 (4.9) | 51 (4.9) | 95 (4.9) | <0.05 |
| Reproductive system and breast disorders | 110 (3.7) | 72 (6.9) | 38 (1.9) | <0.05 |
| Musculoskeletal and connective tissue disorders | 79 (2.6) | 27 (2.6) | 52 (2.7) | <0.05 |
| Eye disorders | 65 (2.2) | 12 (1.2) | 53 (2.7) | >0.05 |
| Total adverse events | 2,993 (100) | 1,044 (100) | 1,949 (100) | |