TABLE 5.
Signal strength of upadacitinib adverse events at PT level in FAERS, ranked by ROR for ages ≥65.
| System organ class (SOC) | Preferred term (PT) | Case reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|---|
| Gastrointestinal disorders | Large intestine polyp | 3 | 61.53 (19.69, 192.28) | 61.01 (19.57, 190.15) | 176.2 | 5.92 (4.5) | 60.7 (23.4) |
| Respiratory, thoracic and mediastinal disorders | Pulmonary thrombosis | 3 | 27.76 (8.9, 86.62) | 27.53 (8.83, 85.8) | 76.56 | 4.78 (3.36) | 27.47 (10.6) |
| Investigations | Blood cholesterol increased | 4 | 22.57 (8.42, 60.53) | 22.32 (8.38, 59.47) | 81.36 | 4.48 (3.2) | 22.28 (9.76) |
| Respiratory, thoracic and mediastinal disorders | Respiratory disorder | 3 | 18.61 (5.97, 58.03) | 18.46 (5.92, 57.54) | 49.48 | 4.2 (2.78) | 18.43 (7.12) |
| Injury, poisoning and procedural complications | Upper limb fracture | 3 | 17.56 (5.63, 54.76) | 17.42 (5.59, 54.29) | 46.38 | 4.12 (2.7) | 17.39 (6.72) |
| Eye disorders | Cataract | 6 | 11.53 (5.14, 25.86) | 11.35 (5.18, 24.86) | 56.67 | 3.5 (2.42) | 11.34 (5.77) |
| Vascular disorders | deep vein thrombosis | 3 | 9.78 (3.14, 30.49) | 9.7 (3.11, 30.23) | 23.43 | 3.28 (1.86) | 9.7 (3.75) |
| Respiratory, thoracic and mediastinal disorders | Pulmonary embolism | 5 | 9.17 (3.79, 22.18) | 9.06 (3.82, 21.46) | 35.86 | 3.18 (2.01) | 9.05 (4.32) |
| Infections and infestations | Herpes zoster | 3 | 6.98 (2.24, 21.74) | 6.92 (2.22, 21.57) | 15.21 | 2.79 (1.37) | 6.92 (2.67) |
| Infections and infestations | Bronchitis | 3 | 6.74 (2.16, 21) | 6.69 (2.15, 20.85) | 14.53 | 2.74 (1.32) | 6.69 (2.58) |
| Infections and infestations | Sepsis | 4 | 4.8 (1.79, 12.88) | 4.76 (1.79, 12.68) | 11.91 | 2.25 (0.98) | 4.76 (2.09) |