Table 2.
Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
---|---|---|---|---|---|
Constitutional | Fatigue | 5 (39%) | 4 (31%) | 2 (15%) | 0 (0%) |
Pain | 6 (46%) | 6 (46%) | 0 (0%) | 0 (0% | |
Fall | 0 (0%) | 0 (0% | 1 (8%) | 0 (0%) | |
Other Constitutional | 3 (23%) | 2 (15%) | 0 (0%) | 0 (0%) | |
Vascular | Hypertension | 0 (0%) | 2 (15%) | 2 (15%) | 0 (0%) |
Headache | 5 (39%) | 1 (8%) | 1 (8%) | 0 (0%) | |
Intracranial Hemorrhage | 0 (0%) | 0 (0% | 1 (8%) | 0 (0%) | |
Gastrointestinal | GERD | 2 (15%) | 3 (23%) | 1 (8%) | 0 (0%) |
Constipation | 2 (15%) | 2 (15%) | 0 (0%) | 0 (0%) | |
Diarrhea | 8 (62%) | 2 (15%) | 0 (0%) | 0 (0%) | |
Anorexia | 4 (31%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Weight Loss | 4 (31%) | 0 (0%) | 0 (0%) | 0 (0%) | |
Dysgeusia | 5 (39%) | 2 (15%) | 0 (0%) | 0 (0%) | |
Nausea / Emesis | 6 (46%) | 0 (0%) | 0 (0%) | 0 (0%) | |
Emesis | 4 (31%) | 0 (0%) | 0 (0%) | 0 (0%) | |
Other GI | 2 (15%) | 3 (23%) | 0 (0%) | 0 (0%) | |
Skin | Stomatitis | 0 (0%) | 0 (0%) | 1 (8%) | 0 (0%) |
Rash | 4 (31%) | 1 (8%) | 1 (8%) | 0 (0%) | |
Hand Foot Syndrome | 2 (15%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Dry Mouth | 4 (31%) | 0 (0%) | 0 (0%) | 0 (0%) | |
Other Skin | 6 (46%) | 2 (15%) | 0 (0%) | 0 (0%) | |
Genitourinary | Bladder Spasms | 0 (0%) | 3 (23%) | 0 (0%) | 0 (0%) |
Other Urinary | 7 (54%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Infection | Fever | 4 (31%) | 0 (0%) | 0 (0%) | 0 (0%) |
Infection | 0 (0%) | 8 (62%) | 0 (0%) | 0 (0%) | |
Pulmonary | Hoarseness | 3 (23%) | 0 (0%) | 0 (0%) | 0 (0%) |
Other Pulmonary | 4 (31%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Musculoskeletal | Arthralgia / Myalgia | 4 (31%) | 2 (15%) | 0 (0%) | 0 (0%) |
Metabolic | Hypertriglyceridemia | 1 (8%) | 2 (15%) | 1 (8%) | 1 (8%) |
Elevated Alkaline Phosphatase | 2 (15%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Elevated GGT | 0 (0%) | 1 (8%) | 2 (15%) | 0 (0%) | |
Hypoalbuminemia | 2 (15%) | 1 (8%) | 0 (0%) | 0 (0%) | |
Elevated Lipase | 0 (0%) | 0 (0%) | 2 (15%) | 0 (0%) | |
Other Metabolic | 6 (46%) | 0 (0%) | 0 (0%) | 0 (0%) | |
Hematologic | Anemia | 4 (31%) | 0 (0%) | 0 (0%) | 0 (0%) |
(AE = Adverse Event)