TABLE II.
Grade 3/4 Toxicity During Induction/Induction Intensification
| Grade 3/4 toxicity | Cohorts 1 + 2 (n = 68), N (%) | Cohort 3 (n = 141), N (%) | P |
|---|---|---|---|
| Infectious toxicitya | |||
| Bacterial | 45 (66.2) | 60 (42.6) | 0.002 |
| Sepsis | 42 (61.8) | 56 (39.7) | |
| Pneumonia | 2 (2.9) | 1 (0.7) | |
| Other | 7 (10.3) | 6 (4.3) | |
| Viral | 13 (19.1) | 9 (6.4) | 0.008 |
| Generalized | 4 (5.9) | 2 (1.4) | |
| Pneumonia | 9 (13.2) | 7 (5.0) | |
| Varicella-Zoster | 1 (1.5) | 0 | |
| Fungal | 9 (13.2) | 3 (2.1) | 0.002 |
| Sepsis | 3 (4.4) | 1 (0.7) | |
| Abscess | 4 (5.9) | 1 (0.7) | |
| Pneumocystis jirovecii | 2 (2.9) | 1 (0.7) | |
| Other | |||
| Infection not otherwise specified | 1 (1.5) | 10 (7.1) | 0.108 |
| Non-hematologic toxicity | |||
| Hemorrhage | 3 (4.4) | 6 (4.3) | 1.000 |
| Thrombosis | 1 (1.5) | 1 (0.7) | 0.546 |
| Cortical (seizure) | 8 (11.8) | 10 (7.1) | 0.296 |
| Diarrhea | 10 (14.7) | 11 (7.8) | 0.142 |
| Local skin | 13 (19.1) | 16 (11.3) | 0.139 |
| Stomatitis | 14 (20.6) | 43 (30.5) | 0.140 |
| Hematologic toxicity | |||
| Absolute neutrophil count | 62 (91.2) | 117 (83.0) | 0.142 |
| Hemoglobin | 58 (85.3) | 111 (78.7) | 0.348 |
| Platelets | 61 (89.7) | 114 (80.9) | 0.114 |
a
Infectious sub-categories do not total to the categories of bacterial, viral, and fungal as N = number affected and not total number of episodes.