Table 4.
Adverse Event | Both Phases | Induction Phase | Maintenance Phase | |||
---|---|---|---|---|---|---|
Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
number of patients (percent) | ||||||
Hematologic | ||||||
| ||||||
Neutropenia | 28 (74) | 19 (50) | 27 (71) | 16 (42) | 21 (55) | 12 (32) |
| ||||||
Anemia | 23 (60) | 4 (11) | 18 (47) | 3 (8) | 11 (29) | 1 (3) |
| ||||||
Thrombocytopenia | 15 (39) | 5 (13) | 11 (29) | 4 (11) | 11 (29) | 2 (5) |
| ||||||
Febrile neutropenia | 2 (5) | 2 (5) | 1 (3) | 1 (3) | 1 (3) | 1 (3) |
| ||||||
Infectious | ||||||
| ||||||
Upper respiratory tract infection | 15 (39) | 0 | 9 (24) | 0 | 11 (29) | 0 |
| ||||||
Urinary tract infection | 7 (18) | 0 | 4 (11) | 0 | 4 (11) | 0 |
| ||||||
Sinusitis | 4 (11) | 0 | 1 (3) | 0 | 3 (8) | 0 |
| ||||||
Cellulitis | 3 (8) | 0 | 2 (5) | 0 | 1 (3) | 0 |
| ||||||
Pneumonia | 3 (8) | 3 (8) | 1 (3) | 1 (3) | 2 (5) | 2 (5) |
| ||||||
Other | ||||||
| ||||||
Fatigue | 28 (74) | 3 (8) | 25 (66) | 3 (8) | 12 (32) | 0 |
| ||||||
Rash | 25 (66) | 11 (29) | 25 (66) | 11 (29) | 0 | 0 |
| ||||||
Fever | 22 (58) | 0 | 19 (50) | 0 | 4 (11) | 0 |
| ||||||
Cough | 21 (55) | 0 | 18 (47) | 0 | 6 (16) | 0 |
| ||||||
Diarrhea | 21 (55) | 0 | 20 (53) | 0 | 14 (37) | 0 |
| ||||||
Hyperglycemia | 19 (50) | 2 (5) | 12 (32) | 2 (5) | 14 (37) | 0 |
| ||||||
Constipation | 17 (45) | 0 | 17 (45) | 0 | 4 (11) | 0 |
| ||||||
Edema | 16 (42) | 0 | 14 (37) | 0 | 3 (8) | 0 |
| ||||||
Inflammatory syndrome (tumor flare) | 13 (34) | 4 (11) | 13 (34) | 4 (11) | 0 | 0 |
| ||||||
Infusion reaction | 13 (34) | 1 (3) | 13 (34) | 1 (3) | 0 | 0 |
| ||||||
Nausea | 12 (32) | 0 | 12 (32) | 0 | 1 (3) | 0 |
| ||||||
Anorexia | 11 (29) | 0 | 10 (26) | 0 | 3 (8) | 0 |
| ||||||
Dyspnea | 11 (29) | 1 (3) | 10 (26) | 1 (3) | 1 (3) | 0 |
| ||||||
Elevated alanine aminotransferase level | 13 (34) | 2 (5) | 9 (24) | 1 (3) | 4 (11) | 1 (3) |
| ||||||
Elevated aspartate aminotransferase level | 11 (29) | 2 (5) | 8 (21) | 1 (3) | 4 (11) | 1 (3) |
| ||||||
Hypothyroidism | 6 (16) | 0 | 6 (16) | 0 | 0 | 0 |
The table includes all treatment-related hematologic and infectious adverse events, as well as other adverse events that occurred in more than 15% of the 38 patients.