Table 3 Safety signal detection among the unknown AEs of infliximab reported in the KAERS between 2009 and 2018.
WHO-ART preferred term | Data mining methods | |||||||
|---|---|---|---|---|---|---|---|---|
GBM | RF | aROR | IC | |||||
Signal | Probability | Signal | Probability | Signal | ROR025a | Signal | IC05b | |
Acne | Y | 0.92 | Y | 0.74 | N | 0.64 | N | − 0.33 |
Alopecia | Y | 0.94 | Y | 0.77 | N | 0.08 | N | − 2.66 |
Asthenia | Y | 1 | Y | 0.95 | N | 0.36 | N | − 1.34 |
Bilirubinaemia | Y | 0.93 | Y | 0.71 | N | 0.02 | N | − 4.37 |
Cytomegalovirus colitis | Y | 0.87 | Y | 0.75 | N | 0.2 | N | − 1.07 |
Death | Y | 0.88 | Y | 0.76 | N | 0.01 | N | − 2.89 |
Drug reaction paradoxical | Y | 0.88 | Y | 0.8 | N | < 0.01 | N | − 0.17 |
Epistaxis | Y | 0.93 | Y | 0.81 | N | 0.78 | N | − 0.63 |
Extravasation | Y | 0.86 | Y | 0.73 | N | 0.03 | N | − 2.11 |
Gastroenteritis | Y | 0.97 | Y | 0.76 | N | < 0.01 | N | − 0.07 |
Haematuria | Y | 0.99 | Y | 0.82 | N | 0.04 | N | − 1.83 |
Hepatocellular damage | Y | 0.88 | Y | 0.67 | N | 0.06 | N | − 3.27 |
Hypoaesthesia | Y | 0.9 | Y | 0.7 | N | 0.14 | N | − 1.39 |
Liver fatty | Y | 0.97 | Y | 0.79 | N | < 0.01 | N | − 0.17 |
Melaena | Y | 0.95 | Y | 0.89 | Y | 2.79 | Y | 0.62 |
Mouth dry | Y | 0.78 | Y | 0.65 | N | 0.26 | N | − 1.06 |
Oedema genital | Y | 0.9 | Y | 0.63 | N | < 0.01 | N | − 1.48 |
Oedema periorbital | Y | 0.88 | Y | 0.64 | N | 0.11 | N | − 1.99 |
Paraesthesia | Y | 0.82 | Y | 0.83 | N | 0.83 | N | − 0.16 |
Psoriasis | Y | 0.87 | Y | 0.71 | N | < 0.01 | Y | 0.19 |
Pulmonary infiltration | Y | 0.97 | Y | 0.82 | N | 0.32 | N | − 0.3 |
Stomatitis ulcerative | Y | 0.89 | Y | 0.78 | N | 0.08 | N | − 1.82 |
Stridor | Y | 0.82 | Y | 0.65 | N | < 0.01 | N | − 1.48 |
Stupor | Y | 0.84 | Y | 0.64 | N | 0.14 | N | − 3.17 |
Temperature changed sensation | Y | 1 | Y | 0.96 | Y | 4.23 | N | − 0.08 |
Tremor | Y | 0.85 | Y | 0.71 | N | 0.2 | N | − 0.8 |
Uveitis | Y | 0.66 | Y | 0.7 | N | < 0.01 | Y | 0.08 |
