Table 2 Signal strength of AEs of daptomycin at the system organ class (SOC) level ranked by ROR.
SOC | a | ROR (95%CI) | PRR (χ2) | EBGM(EBGM05) | BCPNN (IC025) |
|---|---|---|---|---|---|
Hepatobiliary disorders | 12 | 8.54 (4.66–15.65) | 7.61 (69.75) | 69.75 (42.03) | 2.92 (1.23) |
Renal and urinary disorders | 6 | 4.55 (1.99–10.41) | 4.34 (15.58) | 15.58 (7.8) | 2.11 (0.42) |
Infections and infestations | 9 | 3.68 (1.85–7.31) | 3.43 (15.89) | 15.89 (8.95) | 1.78 (0.08) |
Vascular disorders | 6 | 2.87 (1.25–6.55) | 2.75 (6.83) | 6.83 (3.42) | 1.46 (-0.23) |
Injury, poisoning and procedural complications | 16 | 1.3 (0.76–2.23) | 1.25 (0.94) | 0.94 (0.6) | 0.32 (-1.37) |
General disorders and administration site conditions | 14 | 1.29 (0.73–2.27) | 1.25 (0.77) | 0.77 (0.48) | 0.32 (-1.37) |
Skin and subcutaneous tissue disorders | 4 | 1.12 (0.41–3.05) | 1.12 (0.05) | 0.05 (0.02) | 0.16 (-1.53) |
Blood and lymphatic system disorders | 9 | 1 (0.5–1.98) | 1 (0) | 0 (0) | 0 (-1.69) |
Investigations | 3 | 0.95 (0.3–3) | 0.95 (0.01) | 0.01 (0) | -0.07 (-1.76) |
Respiratory, thoracic and mediastinal disorders | 7 | 0.92 (0.43–1.99) | 0.93 (0.05) | 0.05 (0.02) | -0.11 (-1.8) |
Immune system disorders | 1 | 0.86 (0.12–6.17) | 0.86 (0.02) | 0.02 (0) | -0.22 (-1.91) |
Nervous system disorders | 3 | 0.44 (0.14–1.39) | 0.46 (2.07) | 2.07 (0.79) | -1.13 (-2.82) |
Cardiac disorders | 3 | 0.41 (0.13–1.31) | 0.43 (2.4) | 2.4 (0.92) | -1.21 (-2.9) |
Pregnancy, puerperium and perinatal conditions | 1 | 0.36 (0.05–2.61) | 0.37 (1.1) | 1.1 (0.21) | -1.43 (-3.12) |
Metabolism and nutrition disorders | 1 | 0.35 (0.05–2.49) | 0.35 (1.21) | 1.21 (0.23) | -1.5 (-3.19) |
Gastrointestinal disorders | 1 | 0.15 (0.02–1.1) | 0.16 (4.64) | 4.64 (0.89) | -2.63 (-4.32) |
