Table 2.
Number (%) of subjects with most frequently reported (≥5 % of all active-treated subjects) treatment-emergent adverse events by preferred term and treatment
| ch-mAb7F9 |
|||||||
|---|---|---|---|---|---|---|---|
| Preferred Term | Placebo N = 10 | 0.2 mg/kg N = 6 | 0.6 mg/kg N = 6 | 2 mg/kg N = 6a | 6 mg/kg N = 6 | 20 mg/kg N = 7 | All Active-treated N = 32a |
| Blood CPK Increased | 4 (40.0) | 3 (50.0) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 4 (57.1) | 12 (37.5) |
| URI | 2 (20.0) | 0 | 1 (16.7) | 4 (66.7) | 2 (33.3) | 2 (28.6) | 10 (31.3) |
| Hemoglobin Decreased | 5 (50.0) | 2 (33.3) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 3 (42.9) | 10 (31.3) |
| Headache | 2 (20.0) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 2 (28.6) | 6 (18.8) |
| AST Increased | 2 (20.0) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 2 (28.6) | 6 (18.8) |
| Proteinuria | 2 (20.0) | 1 (16.7) | 0 | 2 (33.3) | 2 (33.3) | 1 (14.3) | 6 (18.8) |
| ALT Increased | 2 (20.0) | 2 (33.3) | 0 | 1 (16.7) | 0 | 2 (28.6) | 5 (15.6) |
| WBC Count Decreased | 2 (20.0) | 1 (16.7) | 0 | 1 (16.7) | 0 | 2 (28.6) | 4 (12.5) |
| Nasal Congestion | 2 (20.0) | 0 | 0 | 2 (33.3) | 2 (33.3) | 0 | 4 (12.5) |
| Lipase Increased | 2 (20.0) | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 3 (9.4) |
| Abdominal Pain | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 2 (6.3) |
| Toothache | 1 (10.0) | 0 | 0 | 0 | 1 (16.7) | 1 (14.3) | 2 (6.3) |
| Gastroenteritis | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (14.3) | 2 (6.3) |
| Urinary Tract Infection | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 2 (6.3) |
| Vaginitis Bacterial | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 2 (6.3) |
| Viral Infection | 1 (10.0) | 0 | 1 (16.7) | 0 | 0 | 1 (14.3) | 2 (6.3) |
| Laceration | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (6.3) |
| Sunburn | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (6.3) |
| Blood Calcium Decreased | 2 (20.0) | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (6.3) |
| Blood LDH Increased | 1 (10.0) | 1 (16.7) | 0 | 0 | 0 | 1 (14.3) | 2 (6.3) |
| Oropharyngeal Pain | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (14.3) | 2 (6.3) |
| Blood Potassium Decreased | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (14.3) | 2 (6.3) |
| Platelet Count Decreased | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (6.3) |
Notes: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; LDH = lactate dehydrogenase; URI = upper respiratory tract infection; WBC = white blood cell. aInfusion was stopped/interrupted for one subject due to an adverse event of infusion reaction; therefore, this subject was excluded for the 2 mg/kg group and included in the ‘All Active-treated Subjects’ group.