Table 3 Signal strength of AEs associated with combined ipilimumab and nivolumab therapy at the system organ class (SOC) level in the FAERS database.
System organ class (SOC) | N | ROR (95%Cl) | PRR (χ2) | EBGM(EBGM05) | IC(IC025) |
|---|---|---|---|---|---|
Gastrointestinal disorders | 6540 | 1.44 (1.4–1.48) | 1.39 (768.98) | 1.39 (1.36) | 0.47 (-1.2) |
General disorders and administration site conditions | 6133 | 0.59 (0.57–0.61) | 0.64 (1548.66) | 0.64 (0.62) | -0.65 (-2.32) |
Vascular disorders | 874 | 0.73 (0.69–0.78) | 0.74 (83.74) | 0.74 (0.7) | -0.44 (-2.11) |
Nervous system disorders | 3071 | 0.63 (0.61–0.65) | 0.65 (623) | 0.65 (0.63) | -0.62 (-2.28) |
Psychiatric disorders | 605 | 0.18 (0.17–0.2) | 0.19 (2169.58) | 0.19 (0.18) | -2.37 (-4.04) |
Hepatobiliary disorders | 2975 | 6.21 (5.98–6.44) | 5.93 (12230.4) | 5.9 (5.72) | 2.56 (0.89) |
Respiratory, thoracic and mediastinal disorders | 3523 | 1.38 (1.33–1.42) | 1.35 (337.28) | 1.35 (1.31) | 0.43 (-1.23) |
Cardiac disorders | 1873 | 1.3 (1.24–1.36) | 1.29 (122.39) | 1.29 (1.24) | 0.36 (-1.3) |
Infections and infestations | 3439 | 1.19 (1.15–1.23) | 1.18 (98.75) | 1.18 (1.15) | 0.24 (-1.43) |
Investigations | 3148 | 0.91 (0.88–0.95) | 0.92 (25.12) | 0.92 (0.89) | -0.12 (-1.79) |
Skin and subcutaneous tissue disorders | 3277 | 1.11 (1.07–1.15) | 1.1 (33.39) | 1.1 (1.07) | 0.14 (-1.52) |
Endocrine disorders | 3695 | 28.79 (27.83–29.78) | 26.94 (90003.9) | 26.23 (25.5) | 4.71 (3.05) |
Metabolism and nutrition disorders | 3005 | 2.59 (2.5–2.69) | 2.51 (2777.09) | 2.5 (2.43) | 1.32 (-0.34) |
Renal and urinary disorders | 1651 | 1.57 (1.5–1.65) | 1.56 (335.39) | 1.56 (1.49) | 0.64 (-1.03) |
Musculoskeletal and connective tissue disorders | 1958 | 0.66 (0.63–0.69) | 0.67 (326.56) | 0.67 (0.65) | -0.57 (-2.24) |
Blood and lymphatic system disorders | 1649 | 1.79 (1.71–1.88) | 1.77 (560.23) | 1.77 (1.7) | 0.82 (-0.84) |
Reproductive system and breast disorders | 64 | 0.13 (0.1–0.16) | 0.13 (377.36) | 0.13 (0.11) | -2.95 (-4.61) |
Immune system disorders | 739 | 1.22 (1.13–1.31) | 1.21 (27.76) | 1.21 (1.14) | 0.28 (-1.39) |
Eye disorders | 836 | 0.76 (0.71–0.82) | 0.77 (60.96) | 0.77 (0.72) | -0.38 (-2.05) |
Ear and labyrinth disorders | 144 | 0.59 (0.51–0.7) | 0.6 (39.61) | 0.6 (0.52) | -0.75 (-2.41) |
