Table 6 NCI CTC adverse events related to the study drug
No. of evaluable pts (%) | No. of evaluable cycles (%) | |||||
|---|---|---|---|---|---|---|
No=51 | N =197 * | |||||
Adverse events | Overall incidence | Grade 3 | Grade 4 | Overall incidence | Grade 3 | Grade 4 |
Haematological* | ||||||
Anaemia | 46 (90) | 7 (14) | — | 169 (86) | 10 (5) | — |
Leucopenia | 43 (84) | 14 (28) | 9 (18) | 152 (78) | 41 (21) | 12 (6) |
Neutropenia | 42 (82) | 16 (31) | 18 (35) | 144 (74) | 43 (22) | 39 (20) |
Thrombocytopenia | 22 (43) | 3 (6) | — | 77 (39) | 4 (2) | — |
Febrile neutropenia | 5 (10) | 4 (8) | 1 (2) | 5 (3) | 4 (2) | 1 (1) |
Infection | ||||||
Infection+G 3/4 neutropenia | 3 (6) | 2 (4) | 1 (2) | 4 (2) | 2 (1) | 1 (1) |
Infection without neutropenia | 7 (14) | — | 2 (4) | 10 (5) | — | 2 (1) |
Nonhaematological gastrointestinal | ||||||
Nausea | 19 (37) | 2 (4) | — | 36 (18) | 2 (1) | — |
Vomiting | 13 (226) | 3 (6) | — | 23 (12) | 3 (2) | — |
Constipation | 33 (65) | 3 (6) | 1 (2) | 63 (32) | 3 (25) | 1 (1) |
Anorexia | 4 (8) | 1 (2) | — | 27 (14) | — | — |
Dehydration | 13 (26) | — | — | 4 (2) | 1 (1) | — |
Dysphagia/oesophagitis | 2 (4) | 1 (2) | — | 3 (2) | 1 (1) | — |
Stomatitis | 17 (33) | 3 (6) | — | 34 (17) | 3 (2) | — |
Flu-like symptoms | ||||||
Fatigue | 34 (67) | 5 (10) | — | 93 (47 | 6 (3) | — |
Pain | ||||||
Abdominal pain | 19 (37) | 4 (8) | — | 32 (16) | 6 (3) | — |
Bone pain | 6 (12) | 2 (4) | — | 9 (5) | 2 (1) | — |
Myalgia | 9 (186) | 2 (4) | — | 15 (8) | 2 (1) | — |
Pain-other | 4 (8) | — | — | 5 (3) | — | — |
Neurological | ||||||
Syncope | 1 (2) | 1 (2) | — | 1 (1) | 1 (1) | — |
Neuropathy-sensory | 4 (8) | — | — | 6 (3) | — | — |
Dermatological | ||||||
Alopecia | 20 (39) | NA | NA | 83 (42) | NA | NA |
Injection site reaction | 2 (4) | — | — | 3 (2) | — | — |
Weight loss | 10 (20) | 1 (2) | — | 35 (18) | 4 (2) | — |
