Tot ADRs N (% out of 834) | |
---|---|
N involved patients | 492 |
N ADRs/patients | |
1 | 256 (52.03) |
2 | 155 (31.50) |
3+ | 81 (16.46) |
Age | |
Mean ± standard error, months | 62.53 ± 2.09 |
Age classes | |
New-borns (< 1 month) | 7 (0.84) |
Infants (1–23 months) | 332 (39.81) |
Children (24–143 months) | 368 (44.12) |
Adolescents (144–192 months) | 127 (15.23) |
Sex | |
Male | 449 (53.48) |
Female | 385 (46.16) |
Ethnic group | |
Caucasian | 756 (90.65) |
Others | 25 (3.00) |
Not available | 53 (6.35) |
Tot number of drugs | |
1 | 448 (53.72) |
2 | 255 (30.58) |
3+ | 131 (15.71) |
Seriousness | |
Hospitalization | 224 (26.86) |
Congenital abnormalities/ Deficit | 1 (0.12) |
Other clinically relevant conditions | 14 (1.68) |
Outcome | |
Complete resolution | 48 (5.76) |
Improvement | 483 (57.91) |
Invariant situation/worsening | 18 (2.16) |
Not available | 285 (34.17) |
Drug-drug interactionsa | |
No | 308 (79.79) |
Yes | 78 (20.21) |
Mild | 4 (1.04) |
Moderate | 17 (4.40) |
Severe | 57 (14.77) |
Tot drug ADR-pairs N (% out of 1100) | |
Drugs (vaccines excluded) | 711 (64.64) |
Causality | |
In doubt | 18 |
Possible | 301 |
Probable | 310 |
Certain | 82 |
Vaccines | 389 (35.36) |
Causality | |
Not associable | 6 |
Undefined | 50 |
Associable | 333 |