TABLE 2

Patient Demographics and Case Characteristics

Total Pediatric AE Cases (N = 3251), n (%)AUI AE Cases (N = 2183), n (%)Medication Error AE Cases (N = 423), n (%)Other/Unknown Reason AE Cases (N = 645), n (%)
Age, y
 <2449 (13.8)362 (16.6)38 (9.0)49 (7.6)
 2–<41495 (46.0)1326 (60.7)96 (22.7)73 (11.3)
 4–<6629 (19.3)459 (21.0)99 (23.4)71 (11.0)
 6–<12676 (20.8)35 (1.6)189 (44.7)452 (70.1)
 Exact age unknown (<12)2 (0.1)1 (<0.1)1 (0.2)0 (0.0)
Sex
 Boy1758 (54.1)1218 (55.8)227 (53.7)313 (48.5)
 Girl1491 (45.9)965 (44.2)196 (46.3)330 (51.2)
 Not reported2 (0.1)0 (0.0)0 (0.0)2 (0.3)
Drug administered by
 Self2519 (77.5)2178 (99.8)44 (10.4)297 (46.0)
 Parent321 (9.9)0 (0.0)187 (44.2)134 (20.8)
 Other caregiver313 (9.6)0 (0.0)178 (42.1)135 (20.9)
 Multiple caregivers16 (0.5)0 (0.0)12 (2.8)4 (0.6)
 Sibling16 (0.5)5 (0.2)2 (0.5)9 (1.4)
 Not reported66 (2.0)0 (0.0)0 (0.0)66 (10.2)
Exposure site
 Own residence2936 (90.3)2066 (94.6)371 (87.7)499 (77.4)
 Other residence100 (3.1)61 (2.8)16 (3.8)23 (3.6)
 Other location44 (1.4)17 (0.8)11 (2.6)16 (2.5)
 Multiple locations6 (0.2)0 (0.0)4 (0.9)2 (0.3)
 Not reported165 (5.1)39 (1.8)21 (5.0)105 (16.3)
Product type: dosage formulationa
 Liquid2187 (67.3)1510 (69.2)340 (80.4)337 (52.2)
 Solid1051 (32.3)673 (30.8)84 (19.9)294 (45.6)
 Unknown69 (2.1)22 (1.0)9 (2.1)38 (5.9)
Product type: age formulationa
 Pediatric2456 (75.5)1694 (77.6)338 (79.9)424 (65.7)
 Adult501 (15.4)335 (15.3)34 (8.0)132 (20.5)
 Unknown356 (11.0)181 (8.3)61 (14.4)114 (17.7)
Product type: combination formulationa
 Single-ingredient product2519 (77.5)1780 (81.5)314 (74.2)425 (65.9)
 Fixed-combination product757 (23.3)413 (18.9)122 (28.8)222 (34.4)
 Unknown38 (1.2)16 (0.7)3 (0.7)19 (2.9)
  • a Each case may involve >1 index ingredient, therefore, the total number of ingredients is larger than the number of cases.