Table 4. Commonly Occurring (> 5%) Grade 3/4 Adverse Events1, Including All Grade 4 Adverse Events (By Phase of Study).
| Toxicity | Grade 3 N (%) | Grade 4 N (%) | |
|---|---|---|---|
| Phase 1 (N=27) | |||
| Hematologic | Leukocyte count decreased | 9 (33.3%) | 3 (11.1%) |
| Neutrophil count decreased | 4 (14.8%) | 6 (22.2%) | |
| Lymphocyte count decreased | 2 (7.4%) | 0 (0.0%) | |
| Platelet count decreased | 2 (7.4%) | 0 (0.0%) | |
| Non-Hematologic | Dyspnea | 6 (22.2%) | 0 (0.0%) |
| Dysphagia | 3 (11.1%) | 0 (0.0%) | |
| Fatigue | 2 (7.4%) | 0 (0.0%) | |
| Febrile neutropenia | 2 (7.4%) | 0 (0.0%) | |
| Nausea | 2 (7.4%) | 0 (0.0%) | |
| Pneumonitis | 2 (7.4%) | 0 (0.0%) | |
| Dehydration | 1 (3.7%) | 1 (3.7%) | |
| Hypotension | 1 (3.7%) | 1 (3.7%) | |
| Myocardial ischemia | 0 (0.0%) | 2 (7.4%) | |
| Thrombosis | 0 (0.0%) | 2 (7.4%) | |
| Cardiac troponin I increased | 0 (0.0%) | 1 (3.7%) | |
| Phase II RP2D (N=27) | |||
| Hematologic | Leukocyte count decreased | 13 (48.1%) | 4 (14.8%) |
| Neutrophil count decreased | 12 (44.4%) | 6 (22.2%) | |
| Platelet count decreased | 2 (7.4%) | 10 (37.0%) | |
| Hemoglobin decreased | 2 (7.4%) | 0 (0.0%) | |
| Lymphocyte count decreased | 0 (0.0%) | 1 (3.7%) | |
| Non-Hematologic | Fatigue | 6 (22.2%) | 0 (0.0%) |
| Nausea | 3 (11.1%) | 0 (0.0%) | |
| Dyspnea | 2 (7.4%) | 1 (3.7%) | |
| Anorexia | 2 (7.4%) | 0 (0.0%) | |
| Pneumonitis | 2 (7.4%) | 0 (0.0%) | |
| Syncope | 2 (7.4%) | 0 (0.0%) | |
| Depressed level of consciousness | 1 (3.7%) | 1 (3.7%) | |
| Serum sodium decreased | 1 (3.7%) | 1 (3.7%) | |
| Myalgia | 1 (3.7%) | 1 (3.7%) | |
| Serum potassium decreased | 0 (0.0%) | 1 (3.7%) | |
| Hypoxia | 0 (0.0%) | 1 (3.7%) | |
1
Adverse events reported regardless of attribution