Table 4.
Nonhematologic toxicities possibly related to the study treatment.
| CIA (n = 48) | FIA (n = 33) | |||
|---|---|---|---|---|
|
|
|
|||
| Toxicity | All grades, n (%) | Grade 3/4, n (%) | All grades, n (%) | Grade 3/4, n (%) |
| Cardiac arrhythmia | 0 | 0 | 2 (6) | 0 |
| Colitis | 0 | 0 | 2 (6) | 2 (6) |
| Congestive heart failure | 2 (4) | 2 (4) | 0 | 0 |
| Constipation | 3 (6) | 0 | 2 (6) | 1 (3) |
| Diarrhea | 11 (23) | 1 (2) | 10 (30) | 0 |
| Dyspepsia | 1 (2) | 1 (2) | 3 (9) | 0 |
| Dyspnea | 3 (6) | 1 (2) | 1 (3) | 0 |
| Edema | 4 (8) | 1 (2) | 3 (9) | 0 |
| Elevated ALT/AST | 8 (17) | 0 | 7 (21) | 4 (12) |
| Elevated bilirubin | 16 (33) | 0 | 7 (21) | 0 |
| Elevated creatinine | 7 (15) | 1 (2) | 2 (6) | 0 |
| Febrile neutropenia | 21 (44) | 21 (44) | 9 (27) | 9 (27) |
| Hemorrhage | 7 (15) | 3 (6) | 6 (18) | 4 (12) |
| Hyperglycemia | 1 (2) | 1 (2) | 0 | 0 |
| Hypotension | 3 (6) | 3 (6) | 2 (6) | 1 (3) |
| Infection | 36 (75) | 34 (71) | 22 (66) | 21 (63) |
| Mucositis/stomatitis | 10 (21) | 1 (2) | 6 (18) | 2 (6) |
| Muscle weakness | 3 (6) | 0 | 1 (3) | 1 (3) |
| Nausea/vomiting | 18 (38) | 3 (6) | 12 (36) | 4 (12) |
| Pain | 11 (23) | 7 (15) | 12 (36) | 5 (15) |
| Pancreatitis | 1 (2) | 1 (2) | 0 | 0 |
| Pleural effusion | 0 | 0 | 4 (12) | 0 |
| Pruritus | 3 (6) | 1 (2) | 0 | 0 |
| Rash | 7 (15) | 0 | 3 (9) | 0 |
| Syncope | 1 (2) | 1 (2) | 1 (3) | 1 (3) |
| Venous thromboembolism | 3 (6) | 3 (6) | 0 | 0 |
a
ALT: alanine transaminase; AST: aspartate transaminase.