TABLE 9.
Signal strength of AEs of enasidenib at the System Organ Class. Level in food and drug administration adverse event reporting system (FAERS) database.
|
System Organ Class |
Enasidenib Cases Reporting SOC | ROR enasidenib/ all other cases(95%CI) |
|---|---|---|
| Nervous system disorders | 34 | 0.56 (0.4–0.79) |
| Gastrointestinal disorders | 62 | 0.97 (0.75–1.26) |
| General disorders and administration site conditions | 86 | 0.57 (0.45–0.71) |
| Renal and urinary disorders | 15 | 0.91 (0.55–1.52) |
| Infections and infestations | 168 | 4.51 (3.81–5.35) |
| Metabolism and nutrition disorders | 26 | 1.7 (1.15–2.51) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 109 | 4.08 (3.34–5) |
| Respiratory, thoracic and mediastinal disorders | 55 | 1.56 (1.19–2.05) |
| Vascular disorders | 7 | 0.46 (0.22–0.97) |
| Blood and lymphatic system disorders | 87 | 7.1 (5.69–8.88) |
| Cardiac disorders | 46 | 0.98 (0.73–1.32) |
| Injury, poisoning and procedural complications | 19 | 1.2 (0.76–1.89) |
| Investigations | 22 | 0.21 (0.14–0.32) |
| Musculoskeletal and connective tissue disorders | 11 | 1.68 (0.93–3.05) |
| Skin and subcutaneous tissue disorders | 16 | 0.33 (0.2–0.54) |
| Immune system disorders | 14 | 0.33 (0.2–0.56) |
CI, confidence interval; ROR, reporting odds ratio.