System organ class (SOC) | Case reports | ROR (95% CI) | PRR (95% CI) | EBGM (EBGM05) | IC (IC025) |
---|---|---|---|---|---|
General Disorders And Administration Site Conditions* | 2167 | 1.2 (1.14–1.26) | 1.16 (56.31) | 1.16 (1.11) | 0.21 (-1.46) |
Nervous System Disorders* | 2081 | 2.97 (2.83–3.12) | 2.59 (2187.04) | 2.58 (2.48) | 1.37 (-0.3) |
Psychiatric Disorders* | 1937 | 3.98 (3.79–4.18) | 3.44 (3535.18) | 3.44 (3.3) | 1.78 (0.11) |
Injury, Poisoning And Procedural Complications | 1150 | 0.91 (0.86–0.97) | 0.92 (8.64) | 0.92 (0.88) | -0.12 (-1.78) |
Gastrointestinal Disorders | 673 | 0.77 (0.71–0.83) | 0.78 (43.82) | 0.78 (0.73) | -0.35 (-2.02) |
Musculoskeletal And Connective Tissue Disorders | 342 | 0.62 (0.56–0.69) | 0.63 (77.99) | 0.63 (0.58) | -0.67 (-2.33) |
Investigations | 309 | 0.49 (0.43–0.54) | 0.5 (162.75) | 0.5 (0.46) | -1 (-2.66) |
Surgical And Medical Procedures* | 307 | 2.04 (1.82–2.29) | 2.01 (158.35) | 2.01 (1.83) | 1.01 (-0.66) |
Respiratory, Thoracic And Mediastinal Disorders | 301 | 0.61 (0.54–0.68) | 0.62 (74.08) | 0.62 (0.56) | -0.69 (-2.36) |
Social Circumstances* | 220 | 4.5 (3.94–5.15) | 4.43 (586.21) | 4.43 (3.96) | 2.15 (0.48) |
Infections And Infestations | 185 | 0.3 (0.26–0.35) | 0.32 (290.38) | 0.32 (0.28) | -1.66 (-3.33) |
Skin And Subcutaneous Tissue Disorders | 176 | 0.27 (0.23–0.31) | 0.28 (340.69) | 0.28 (0.25) | -1.82 (-3.49) |
Metabolism And Nutrition Disorders | 138 | 0.65 (0.55–0.77) | 0.66 (25.25) | 0.66 (0.57) | -0.61 (-2.27) |
Cardiac Disorders | 133 | 0.61 (0.52–0.73) | 0.62 (32.48) | 0.62 (0.53) | -0.7 (-2.36) |
Eye Disorders | 122 | 0.58 (0.49–0.7) | 0.59 (35.54) | 0.59 (0.51) | -0.76 (-2.43) |
Renal And Urinary Disorders | 71 | 0.33 (0.26–0.41) | 0.33 (97.69) | 0.33 (0.27) | -1.59 (-3.26) |
Vascular Disorders | 68 | 0.34 (0.26–0.43) | 0.34 (88.92) | 0.34 (0.28) | -1.56 (-3.22) |
Immune System Disorders | 41 | 0.31 (0.23–0.42) | 0.31 (62.67) | 0.31 (0.24) | -1.68 (-3.34) |
Product Issues | 41 | 0.21 (0.15–0.28) | 0.21 (122.82) | 0.21 (0.16) | -2.24 (-3.91) |
Ear And Labyrinth Disorders | 39 | 0.87 (0.63–1.19) | 0.87 (0.8) | 0.87 (0.67) | -0.21 (-1.87) |
Congenital, Familial And Genetic Disorders | 34 | 1.17 (0.84–1.64) | 1.17 (0.87) | 1.17 (0.89) | 0.23 (-1.44) |
Hepatobiliary Disorders | 26 | 0.29 (0.2–0.43) | 0.29 (45.25) | 0.29 (0.21) | -1.78 (-3.45) |
Reproductive System And Breast Disorders | 22 | 0.32 (0.21–0.48) | 0.32 (32.11) | 0.32 (0.23) | -1.65 (-3.31) |
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | 18 | 0.05 (0.03–0.08) | 0.05 (324.06) | 0.05 (0.04) | -4.27 (-5.94) |
Endocrine Disorders | 7 | 0.25 (0.12–0.52) | 0.25 (15.83) | 0.25 (0.13) | -2 (-3.67) |
Blood And Lymphatic System Disorders | 6 | 0.03 (0.01–0.07) | 0.03 (170.9) | 0.03 (0.02) | -4.9 (-6.57) |