Table II. TRAEs, SAEs, and DLTs.
| Adverse Event | Any Grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
| Any | 20 | 17 | 13 | 3 | 2 |
| Abdominal pain | 2 | 1 | 1a | ||
| Allergic reaction | 1 | 1a | |||
| Anemia | 8 | 7 | 1 | ||
| Constipation | 2 | 2 | |||
| Cough | 1 | 1 | |||
| Diarrhea | 2 | 2 | |||
| Fatigue | 7 | 6 | 1 | ||
| Fever/Chills | 5 | 5b | |||
| Hyperglycemia | 1 | 1 | |||
| Hypoalbuminemia | 2 | 1 | 1 | ||
| Hypocalcemia | 6 | 3 | 3 | ||
| Hypokalemia | 3 | 3 | |||
| Hyponatremia | 4 | 4 | |||
| Hypomagnesemia | 2 | 2 | |||
| Injection-site reaction | 2 | 1c | 1 | ||
| Leukopenia, not specified | 5 | 3 | 1 | 1 | |
| Lymphopenia | 4 | 1 | 3 | ||
| Nausea | 3 | 3 | |||
| Neutropenia | 7 | 3 | 4c | 1c | |
| Musculoskeletal pain | 3 | 2 | 1 | ||
| Shortness of breath | 2 | 1 | 1a | ||
| Strep throat | 1 | 1 | |||
| Thrombocytopenia | 2 | 1 | 1 | ||
| Upper respiratory infection | 1 | 1 |
Additional grade 1 events were observed in one patient: alanine aminotransferase increase, aspartate aminotransferase increase, creatinine increase, headache, hypermagnesemia, hypotension, rhinitis, sensory neuropathy, shortness of breath, urinary tract infection, and weight loss.
a
SAEs: hospitalization for abdominal pain (n = 1), unrelated to treatment; hospitalization for shortness of breath (n = 1), unrelated to treatment; and allergic reaction to leukocyte growth factor (n = 1), patient removed from study.
b
Regimen was interrupted (fever [n = 1]).
c
DLTs: neutropenia (n = 3), dose reduced; injection-site reaction (n = 1), therapy discontinued.