Table 3. Infusion-related and drug-related treatment emergent AEs.
| Multiple, 21 mg/kg | Single, 7.5 mg/kg | Single, 10 mg/kg | |
| Total number of patients randomised | N = 63 | N = 21 | N = 40 |
| Number of patients with any infusion-related AE, n (%) | 22 (35) | 4 (19) | 17 (43) |
| Infusion related AE by MedDRA preferred term | |||
| Vomiting | 2 (3) | 0 (0) | 0 (0) |
| Chills | 0 (0) | 0 (0) | 1 (3) |
| Pyrexia | 17 (27) | 0 (0) | 14 (35) |
| Arthalgia | 4 (6) | 3 (14) | 1 (3) |
| Back Pain | 1 (2) | 1 (5) | 2 (5) |
| Hypertension | 1 (2) | 0 (0) | 0 (0) |
| Number of patients with TEADR, n (%) * (with cumulate incidence of 10% or greater in any group) | 56 (89) | 20 (95) | 36 (90) |
| TEADR by MedDRA preferred term | |||
| Anaemia | 3 (5) | 1 (5) | 7 (18) |
| Thrombocytosis | 5 (8) | 0 (0) | 6 (15) |
| Pyrexia | 20 (32) | 1 (5) | 14 (35) |
| Alanine aminotransferase increased | 17 (27) | 13 (62) | 11 (28) |
| Asparate aminotransferatase increased | 22 (35) | 14 (67) | 13 (33) |
| Blood creatinine increased | 9 (14) | 1 (5) | 4 (10) |
| Blood magnesium abnormal | 2 (3) | 0 (0) | 4 (10) |
| Blood magnesium decreased | 10 (16) | 9 (43) | 6 (15) |
| Blood potassium decreased | 4 (6) | 9 (43) | 1 (3) |
| Blood sodium decreased | 8 (13) | 7 (33) | 1 (3) |
| Hypermagnesaemia | 6 (10) | 0 (0) | 4 (10) |
| Hypokalaemia | 30 (48) | 4 (19) | 16 (40) |
| Hypomagnesaemia | 7 (11) | 0 (0) | 8 (20) |
| Arthralgia | 4 (6) | 3 (14) | 1 (3) |
| Azotaemia | 8 (13) | 0 (0) | 8 (20) |
| Renal impairment | 0 (0) | 0 (0) | 4 (10)** |
TEADR = treatment emergent adverse drug reaction; treatment emergent = onset between day 1 and day 60 inclusive; adverse drug reaction if investigator judged relationship to treatment as “probable”, “possible” or “unlikely”.
This includes patients with infusion related reactions.
Renal impairment: 3 mild cases and 1 moderate as graded by investigator, all resolved during study period.