The incidence rate (events/100 patient-years) of AE and ADR classified by SOC in RA patients treated with tocilizumab
| Total AE | Serious AE | Total ADR | Serious ADR | |||||
|---|---|---|---|---|---|---|---|---|
| No of events | No of events | No of events | No of events | |||||
| SOC | (/100 patient-years) | (/100 patient-years) | (/100 patient-years) | (/100 patient-years) | ||||
| Total | 3,004 | (167.49) | 490 | (27.32) | 2,330 | (129.91) | 363 | (20.24) |
| Infections and infestations | 553 | (30.83) | 163 | (9.09) | 447 | (24.92) | 147 | (8.20) |
| Laboratory test abnormalities | 636 | (35.46) | 39 | (2.17) | 563 | (31.39) | 36 | (2.01) |
| Hepatobiliary disorders | 269 | (15.00) | 12 | (0.67) | 213 | (11.88) | 11 | (0.61) |
| Skin and subcutaneous tissue disorders | 247 | (13.77) | 6 | (0.33) | 205 | (11.43) | 6 | (0.33) |
| Gastrointestinal disorders | 221 | (12.32) | 42 | (2.34) | 145 | (8.08) | 30 | (1.67) |
| Respiratory, thoracic and mediastinal disorders | 207 | (11.54) | 37 | (2.06) | 150 | (8.36) | 26 | (1.45) |
| Metabolism and nutrition disorders | 172 | (9.59) | 4 | (0.22) | 159 | (8.87) | 3 | (0.17) |
| General disorders and administration site conditions | 145 | (8.08) | 18 | (1.00) | 124 | (6.91) | 16 | (0.89) |
| Musculoskeletal and connective tissue disorders | 135 | (7.53) | 20 | (1.12) | 87 | (4.85) | 12 | (0.67) |
| Nervous system disorders | 102 | (5.69) | 21 | (1.17) | 70 | (3.90) | 13 | (0.72) |
| Blood and lymphatic system disorders | 64 | (3.57) | 23 | (1.28) | 51 | (2.84) | 19 | (1.06) |
| Vascular disorders | 63 | (3.51) | 13 | (0.72) | 33 | (1.84) | 7 | (0.39) |
| Injury, poisoning and procedural complications | 53 | (2.96) | 34 | (1.90) | 5 | (0.28) | 3 | (0.17) |
| Cardiac disorders | 45 | (2.51) | 25 | (1.39) | 33 | (1.84) | 17 | (0.95) |
| Renal and urinary disorders | 21 | (1.17) | 5 | (0.28) | 12 | (0.67) | 3 | (0.17) |
| Eye disorders | 20 | (1.12) | 1 | (0.06) | 10 | (0.56) | 1 | (0.06) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 18 | (1.00) | 15 | (0.84) | 7 | (0.39) | 5 | (0.28) |
| Psychiatric disorders | 11 | (0.61) | 2 | (0.11) | 2 | (0.11) | 0 | (0.00) |
| Immune system disorders | 8 | (0.45) | 7 | (0.39) | 8 | (0.45) | 7 | (0.39) |
| Ear and labyrinth disorders | 6 | (0.33) | 2 | (0.11) | 3 | (0.17) | 1 | (0.06) |
| Endocrine disorders | 4 | (0.22) | 1 | (0.06) | 1 | (0.06) | 0 | (0.00) |
| Reproductive system and breast disorders | 4 | (0.22) | 0 | (0.00) | 2 | (0.11) | 0 | (0.00) |
ADR, adverse drug reaction; AE, adverse event; RA, rheumatoid arthritis; SOC, Medical Dictionary for Regulatory Activities (MedDRA) system organ class (MedDRA v12.0).