Table 2.
Adverse events during the acute period (days 0–21) that were considered related to GMCI or any treatment emergent laboratory events. Grading is based on the National Cancer Institute CTCAE version 3.0
| Related Clinical Events | # of Patients | Adverse Event | Dose Level 1 (n = 3) | Dose Level 2 (n = 5) | ||||
|---|---|---|---|---|---|---|---|---|
| CTC 1 | CTC 2 | CTC 3 | CTC 1 | CTC 2 | CTC 3 | |||
| Cardiac | 1 | Sinus tachycardia | 1 | |||||
| Gastrointestinal | 3 | Abdominal pain | 1 | |||||
| Nausea | 2 | |||||||
| Vomiting | 1 | 1 | ||||||
| General disorders | 3 | Fatigue | 1 | 1 | 1 | |||
| Fever | 2 | |||||||
| Metabolism and nutrition disorders | 1 | Anorexia | 1 | |||||
| Nervous system disorders | 1 | Headache | 1 | |||||
| Hypoglossal nerve disorder | 1 | |||||||
| Numbness, face, arm, legs | 1 | |||||||
| Respiratory disorders | 1 | Dyspnea | 1 | |||||
| Laboratory events | ||||||||
| Metabolic | 6 | Hypocalcemia | 1 | |||||
| Hypokalemia | 1 | |||||||
| Hyponatremia | 1 | 2 | 1 | |||||
| Hematologic | 7 | Anemia | 1 | 1 | ||||
| Leukopenia | 2 | |||||||
| Lymphocytopenia | 1 | 1 | ||||||
| Thrombocytopenia | 1 | |||||||