Table 3.
Incidence of most common treatment‐emergent adverse events, laboratory parameters, and comedications of interest in each treatment arm (SAF)
| Adverse event | Arm 1 (n = 289) | Arm 2 (n = 291) | Arm 3 (n = 277) |
|---|---|---|---|
| Overall | 259 (89.6) | 258 (88.7) | 244 (88.1) |
| Blood and lymphatic system disorders | |||
| Anemia | 97 (33.6) | 84 (28.9) | 87 (31.4) |
| Leukopenia | 50 (17.3) | 49 (16.8) | 52 (18.8) |
| Thrombocytopenia | 50 (17.3) | 50 (17.2) | 44 (15.9) |
| Gastrointestinal disorders | |||
| Diarrhea | 88 (30.5) | 84 (28.9) | 84 (30.3) |
| Nausea | 60 (20.8) | 42 (14.4) | 47 (17.0) |
| Abdominal pain | 33 (11.4) | 38 (13.1) | 34 (12.3) |
| Constipation | 26 (9.0) | 32 (11.0) | 46 (16.6) |
| Vomiting | 38 (13.1) | 31 (10.7) | 31 (11.2) |
| Metabolism and nutrition disorders | |||
| Hyperglycemia | 49 (17.0) | 54 (18.6) | 37 (13.4) |
| Hyperkalemia | 41 (14.2) | 42 (14.4) | 29 (10.5) |
| Hypokalemia | 24 (8.3) | 30 (10.3) | 25 (9.0) |
| Renal and urinary disorders | |||
| Renal failure | 75 (26.0) | 61 (21.0) | 55 (19.9) |
| Acute renal failure | 29 (10.0) | 26 (8.9) | 23 (8.3) |
| Proteinuria | 4 (1.4) | 4 (1.4) | 1 (0.4) |
| General disorders and administration site disorders | |||
| Pyrexia | 44 (15.2) | 35 (12.0) | 45 (16.2) |
| Peripheral edema | 32 (11.1) | 35 (12.0) | 32 (11.6) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pleural effusion | 75 (26.0) | 55 (18.9) | 54 (19.5) |
| Immune system disorders | |||
| Liver transplant rejection | 56 (19.4) | 38 (13.1) | 53 (19.1) |
| Hepatobiliary disorders | |||
| Cholestasis | 38 (13.1) | 44 (15.1) | 44 (15.9) |
| Psychiatric disorders | |||
| Insomnia | 28 (9.7) | 36 (12.4) | 35 (12.6) |
| Musculoskeletal and connective tissue disorders | |||
| Back pain | 32 (11.1) | 28 (9.6) | 21 (7.6) |
| Adverse events of special interest | |||
| Diabetes mellitus* | 11 (3.8) | 13 (4.5) | 11 (4.0) |
| Neurological disorders | 94 (32.5) | 103 (35.4) | 89 (32.1) |
| Tremor | 30 (10.4) | 29 (10.0) | 30 (10.8) |
| Vascular disorders | 83 (28.7) | 96 (33.0) | 94 (33.9) |
| Hypertension | 62 (21.5) | 74 (25.4) | 74 (26.7) |
| Hypotension | 30 (10.4) | 34 (11.7) | 26 (9.4) |
| Laboratory parameters | |||
| Total cholesterol, mmol/L | 4.038 | 4.011 | 4.174 |
| HDL, mmol/L | 1.063 | 1.047 | 1.140 |
| LDL, mmol/L | 2.368 | 2.378 | 2.466 |
| Triglycerides, mmol/L | 1.537 | 1.438 | 1.469 |
| Comedications of interest† | |||
| Antihyperlipidemic medications | 20 (6.9) | 24 (8.2) | 26 (9.4) |
| Antihypertensive medications | 98 (33.9) | 98 (33.7) | 88 (31.8) |
Results are reported in ≥ 10% of patients and shown as n (%); SAF, safety‐analysis set. *Diabetes mellitus was defined as elevated fasting blood glucose levels of > 7 mmol/L 2 on two or more occasions or by the administration of long‐term antidiabetic treatment. †Medications that could be prescribed for more than one indication are included.