Table 3.
Most common adverse events
| MedDRA/J (Version.13.0) preferred term –n (%) | Study 1 (relapsers) N = 109 | Study 2 (nonresponders) N = 32 | Total N = 141 |
|---|---|---|---|
| Anaemia | 96 (88.1) | 32 (100.0) | 128 (90.8) |
| Pyrexia | 90 (82.6) | 30 (93.8) | 120 (85.1) |
| White blood cell count decreased | 83 (76.1) | 22 (68.8) | 105 (74.5) |
| Blood uric acid increased | 72 (66.1) | 25 (78.1) | 97 (68.8) |
| Platelet count decreased | 73 (67.0) | 22 (68.8) | 95 (67.4) |
| Malaise | 60 (55.0) | 23 (71.9) | 83 (58.9) |
| Decreased appetite | 56 (51.4) | 15 (46.9) | 71 (50.4) |
| Hyaluronic acid increased | 56 (51.4) | 15 (46.9) | 71 (50.4) |
| Rash | 39 (35.8) | 16 (50.0) | 55 (39.0) |
| Headache | 42 (38.5) | 10 (31.3) | 52 (36.9) |
| Blood creatinine increased | 36 (33.0) | 12 (37.5) | 48 (34.0) |
| Insomnia | 34 (31.2) | 11 (34.4) | 45 (31.9) |
| Blood bilirubin increased | 34 (31.2) | 10 (31.3) | 44 (31.2) |
| Alopecia | 35 (32.1) | 7 (21.9) | 42 (29.8) |
| Diarrhoea | 31 (28.4) | 7 (21.9) | 38 (27.0) |
| Dysgeusia | 29 (26.6) | 6 (18.8) | 35 (24.8) |
| Vomiting | 26 (23.9) | 8 (25.0) | 34 (24.1) |
| Drug eruption | 24 (22.0) | 10 (31.3) | 34 (24.1) |
| Nausea | 24 (22.0) | 4 (12.5) | 28 (19.9) |
| Abdominal discomfort | 22 (20.2) | 6 (18.8) | 28 (19.9) |
| Blood triglycerides increased | 19 (17.4) | 8 (25.0) | 27 (19.1) |
| Pruritus | 20 (18.3) | 2 (6.3) | 22 (15.6) |
| Arthralgia | 18 (16.5) | 4 (12.5) | 22 (15.6) |
| Nasopharyngitis | 19 (17.4) | 2 (6.3) | 21 (14.9) |
| Stomatitis | 13 (11.9) | 6 (18.8) | 19 (13.5) |
| Back pain | 12 (11.0) | 5 (15.6) | 17 (12.1) |
| Blood phosphorus decreased | 10 (9.2) | 6 (18.8) | 16 (11.3) |
The adverse events listed are those that were reported in at least 15% of patients in each clinical study.