Table 2.
Adverse Events Across All Cycles of Treatment for All Patients Receiving at Least One Cycle of Treatment
| Adverse Event | Grade 2 |
Grade 3 |
Grade 4 |
Grade 2-4 (%) | All Grades (%) | |||
|---|---|---|---|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | No. of Patients | % | |||
| GI | ||||||||
| Colitis | 1 | 3 | 3 | 3 | ||||
| Diarrhea | 6 | 18 | 2 | 6 | 24 | 88 | ||
| Hemorrhage, GI/lower GI NOS | 1 | 3 | 3 | 3 | ||||
| Dehydration | 3 | 9 | 1 | 3 | 12 | 21 | ||
| Abdominal gas/bloating | 0 | 3 | ||||||
| Flatulence | 0 | 3 | ||||||
| Anorexia | 11 | 32 | 32 | 71 | ||||
| Dry mouth | 0 | 3 | ||||||
| Heartburn/dyspepsia | 0 | 3 | ||||||
| Nausea | 8 | 24 | 24 | 79 | ||||
| Taste alteration/dysgeusia | 0 | 27 | ||||||
| Vomiting | 6 | 18 | 18 | 44 | ||||
| Dermatologic | ||||||||
| Rash (acneiform) | 9 | 27 | 2 | 6 | 33 | 74 | ||
| Rash (desquamation) | 3 | 9 | 9 | 18 | ||||
| Pruritus | 1 | 3 | 3 | 9 | ||||
| Dry skin | 0 | 24 | ||||||
| Alopecia | 4 | 12 | 12 | 29 | ||||
| Nail changes | 1 | 3 | 3 | 9 | ||||
| Metabolic | ||||||||
| Hyponatremia | 1 | 3 | 3 | 15 | ||||
| Elevated BUN | 0 | 3 | ||||||
| Acidosis (metabolic) | 1 | 3 | 3 | 3 | ||||
| Hypoalbuminemia | 2 | 6 | 6 | 21 | ||||
| Elevated alkaline phosphatase | 0 | 3 | ||||||
| Elevated ALT | 0 | 3 | ||||||
| Elevated AST | 0 | 9 | ||||||
| Hyperbilirubinemia | 0 | 3 | ||||||
| Hypocalcemia | 1 | 3 | 3 | 6 | ||||
| Elevated creatinine | 1 | 3 | 3 | 3 | ||||
| Elevated chloride | 0 | 3 | ||||||
| Hyperkalemia | 0 | 3 | ||||||
| Hypokalemia | 0 | 3 | ||||||
| Low magnesium | 0 | 3 | ||||||
| Hematologic | ||||||||
| Anemia/hemoglobin | 8 | 24 | 2 | 6 | 30 | 53 | ||
| Platelets | 2 | 6 | 1 | 3 | 9 | 29 | ||
| Hyperglycemia | 1 | 3 | 3 | 12 | ||||
| Leukocytes | 2 | 6 | 6 | 12 | ||||
| Neutrophils/neutropenia | 0 | 9 | ||||||
| Infection | ||||||||
| Infection with normal ANC–lung (pneumonia) | 1 | 3 | 3 | 3 | ||||
| Opportunistic infection associated with ≥ grade 2 lymphopenia | 1 | 3 | 3 | 3 | ||||
| Colitis (infection) | 1 | 3 | 3 | 3 | ||||
| Lymphopenia | 12 | 35 | 5 | 15 | 1 | 3 | 53 | 65 |
| Mucositis (oral) | 1 | 3 | 3 | 27 | ||||
| Musculoskeletal | ||||||||
| Edema, hands | 0 | 3 | ||||||
| Muscle weakness (generalized) | 1 | 3 | 3 | 3 | ||||
| Neuropathy | ||||||||
| Sensory | 0 | 6 | ||||||
| Respiratory | ||||||||
| Dyspnea | 4 | 12 | 1 | 3 | 15 | 15 | ||
| Cough | 1 | 3 | 1 | 3 | 6 | 9 | ||
| Wheezing, bronchospasm | 0 | 3 | ||||||
| Pleural effusion | 6 | 18 | 18 | 35 | ||||
| Pain | ||||||||
| Throat | 1 | 3 | 3 | 6 | ||||
| Mouth | 1 | 3 | 3 | 3 | ||||
| Chest/thorax NOS | 0 | 3 | ||||||
| Joint | 0 | 3 | ||||||
| Muscle | 0 | 3 | ||||||
| Nail bed | 0 | 3 | ||||||
| Pain, abdomen NOS | 0 | 6 | ||||||
| Pain/headache | 1 | 3 | 3 | 12 | ||||
| Cardiac | ||||||||
| Cardiac general, tachycardia | 0 | 3 | ||||||
| Prolonged QTc interval | 1 | 3 | 3 | 3 | ||||
| Constitutional | ||||||||
| Fatigue | 15 | 44 | 44 | 74 | ||||
| Fever | 1 | 3 | 3 | 12 | ||||
| Weight loss | 2 | 6 | 6 | 15 | ||||
| Other | ||||||||
| Dizziness | 0 | 9 | ||||||
| Dry eye syndrome | 0 | 3 | ||||||
| Mood swings | 1 | 3 | 3 | 3 | ||||
| Rigors/chills | 0 | 3 | ||||||
| Hypothyroid | 0 | 3 | ||||||
| Blurred vision | 0 | 3 | ||||||
NOTE. Each patient is reported once, at maximum grade for each adverse event. One grade 5 sudden death occurred in cohort 3 and was considered as possibly related to study treatment.
Abbreviations: NOS, not otherwise specified; BUN, blood urea nitrogen; ANC, absolute neutrophil count.