Non-serious drug-ADR pairs N (% out of 765) | Serious drug-ADRs pairs N (% out of 335) | p-value | Adjusted ROR of serious ADR [95% CI] | p-value | |
---|---|---|---|---|---|
Age classes (FDA classification) | |||||
Adolescents (144–192 months) | 86 (11.24) | 72 (21.49) | < 0.001 | Ref | |
Children (24–143 months) | 335 (43.79) | 123 (36.72) | 0.41 [0.27–0.61] | < 0.001 | |
Infants (1–23 months) | 336 (43.92) | 137 (40.90) | 0.47 [0.32–0.71] | 0.001 | |
New-borns (< 1 month) | 8 (1.05) | 3 (0.90) | 0.42 [0.10–1.70] | 0.224 | |
Sex | |||||
Male | 353 (46.14) | 144 (42.99) | 0.333 | Ref. | |
Female | 412 (53.86) | 191 (57.01) | 0.77 [0.59–1.02] | 0.072 | |
Tot number of drugs | |||||
1 | 347 (45.36) | 101 (30.15) | < 0.001 | Ref. | |
2 | 276 (36.08) | 128 (38.21) | 1.87 [1.33–2.62] | < 0.001 | |
3+ | 142 (18.56) | 106 (31.64) | 3.01 [2.07–4.37] | < 0.001 | |
Drug-drug interactions | |||||
No | 268 (64.11) | 165 (70.51) | 0.097 | ||
Yes | 150 (35.89) | 69 (29.49) | 0.77 [0.54–1.11] | 0.166 | |
Off-label vs on-label usea | |||||
On-Label | 447 (92.36) | 201 (88.94) | 0.133 | Ref. | |
Off-label | 37 (7.64) | 25 (11.06) | 1.56 [0.90–2.73] | 0.115 |