Table 1.
Demographic characteristics and distribution for sex, age, seriousness, the type of reporter, country, involving aripiprazole, and risperidone recognized in the EudraVigilance spontaneous reporting system from 2016 to 2018 in pediatric population (3–17 years).
| Total | Aripiprazole | Risperidone | |
|---|---|---|---|
| ICSR | 3,097 | 855 | 2,242 |
| M (%) | 2,490 (80.4) | 555 (65.0) | 1,935 (86.3) |
| F (%) | 578 (18.7) | 282 (33.0) | 296 (13.2) |
| Not specified | 29 (0.9) | 18 (2.1) | 11 (0.5) |
| Mean age, y (±SD) | 12 (± 3.5) | 13 (±3.6) | 11.6 (±3.4) |
| Overall AEs | 11,042 | 2,993 | 8,049 |
| AEs serious (%) | 10,001 (90.6) | 2,425 (81.0) | 7,576 (94.1) |
| N. of AEs per ICSR; Mean (±SD) | 3.6 (±2.9) | 3.5 (± 3.2) | 3.6 (±2.8) |
| HCP Primary source (%) | 2,809 (90.7) | 735 (86.0) | 2,074 (92.5) |
| N-HCP Primary source | 288 (9.3) | 120 (14.0) | 168 (7.5) |
| Country-EEA | 830 (26.8) | 380 (44.4) | 450 (20.1) |
| Country-NEEA | 2,267 (73.2) | 475 (55.6) | 1,792 (79.9) |
ICSR, individual case safety report; SD, standard deviation; AEs, adverse events; HCP, healthcare professional; N-HCP, non-healthcare professional; EEA, European Economic Area; NEEA, Non-European Economic Area.