Table 2 Adverse event
HR070803 group (n = 147) | Placebo group (n = 149) | |||
|---|---|---|---|---|
Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
Any | 146 (99.3) | 78 (53.1) | 145 (97.3) | 69 (46.3) |
Nausea | 91 (61.9) | 2 (1.4) | 60 (40.3) | 0 |
Vomiting | 85 (57.8) | 7 (4.8) | 48 (32.2) | 3 (2.0) |
Asthenia | 78 (53.1) | 6 (4.1) | 63 (42.3) | 3 (2.0) |
Decreased appetite | 67 (45.6) | 4 (2.7) | 50 (33.6) | 2 (1.3) |
Diarrhea | 67 (45.6) | 6 (4.1) | 36 (24.2) | 4 (2.7) |
Anemia | 59 (40.1) | 9 (6.1) | 52 (34.9) | 4 (2.7) |
Neutrophil count decreased | 49 (33.3) | 19 (12.9) | 12 (8.1) | 0 |
Weight decreased | 48 (32.7) | 1 (0.7) | 36 (24.2) | 1 (0.7) |
White blood cell count decreased | 46 (31.3) | 12 (8.2) | 15 (10.1) | 1 (0.7) |
Alanine aminotransferase increased | 41 (27.9) | 6 (4.1) | 27 (18.1) | 3 (2.0) |
Aspartate aminotransferase increased | 40 (27.2) | 2 (1.4) | 32 (21.5) | 2 (1.3) |
Gamma-glutamyltransferase increased | 38 (25.9) | 28 (19.1) | 33 (22.2) | 17 (11.4) |
Constipation | 33 (22.5) | 0 | 46 (30.9) | 1 (0.7) |
Hypoalbuminemia | 31 (21.1) | 0 | 34 (22.8) | 2 (1.3) |
Abdominal pain | 28 (19.1) | 6 (4.1) | 32 (21.5) | 5 (3.4) |
Platelet count decreased | 25 (17.0) | 0 | 21 (14.1) | 0 |
Pyrexia | 24 (16.3) | 0 | 16 (10.7) | 1 (0.7) |
Hypokalemia | 23 (15.7) | 7 (4.8) | 19 (12.8) | 4 (2.7) |
Back pain | 21 (14.3) | 0 | 25 (16.8) | 4 (2.7) |
Abdominal pain upper | 21 (14.3) | 1 (0.7) | 17 (11.4) | 1 (0.7) |
Blood bilirubin increased | 20 (13.6) | 11 (7.5) | 23 (15.4) | 8 (5.4) |
Blood alkaline phosphatase increased | 18 (12.2) | 6 (4.1) | 29 (19.5) | 5 (3.4) |
Dizziness | 17 (11.6) | 0 | 20 (13.4) | 0 |
Insomnia | 15 (10.2) | 0 | 11 (7.4) | 0 |
Oedema peripheral | 15 (10.2) | 0 | 4 (2.7) | 0 |
Abdominal distension | 14 (9.5) | 1 (0.7) | 25 (16.8) | 0 |
Hyponatremia | 13 (8.8) | 4 (2.7) | 16 (10.7) | 4 (2.7) |
Lymphocyte count decreased | 10 (6.8) | 2 (1.4) | 15 (10.1) | 2 (1.3) |
