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) | — |
*
One cycle was not evaluable for haematological toxicity.