Table 3.
Common Adverse Events, n (%) | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 |
---|---|---|---|---|
Pyrexia | 25 (44) | 1 (2) | 0 | 0 |
Nausea | 23 (40) | 0 | 0 | 0 |
Vomiting | 20 (35) | 0 | 0 | 0 |
Diarrhea | 18 (32) | 1 (2) | 0 | 0 |
Decreased appetite | 17 (30) | 0 | 0 | 0 |
Asthenia | 16 (28) | 2 (4) | 0 | 0 |
Dry skin | 14 (25) | 1 (2) | 0 | 0 |
Peripheral edema | 13 (23) | 0 | 0 | 0 |
Chills | 12 (21) | 1 (2) | 0 | 0 |
Cough | 12 (21) | 0 | 0 | 0 |
Rash | 11 (19) | 1 (2) | 0 | 0 |
Arthralgia | 11 (19) | 0 | 0 | 0 |
Constipation | 10 (18) | 0 | 0 | 0 |
Fatigue | 9 (16) | 1 (2) | 0 | 0 |
Blood alkaline phosphatase increased | 9 (16) | 0 | 0 | 0 |
Dyspnea | 8 (14) | 2 (4) | 0 | 0 |
Pruritis | 8 (14) | 1 (2) | 0 | 0 |
Dizziness | 8 (14) | 0 | 0 | 0 |
Anemia | 7 (12) | 2 (4) | 1 (2) | 0 |
Weight decreased | 7 (12) | 1 (2) | 0 | 0 |
Upper abdominal pain | 7 (12) | 0 | 0 | 0 |
Hypotension | 7 (12) | 0 | 0 | 0 |
Neutropenia | 6 (11) | 5 (9) | 0 | 0 |
Chest pain | 6 (11) | 0 | 0 | 0 |
Dysgeusia | 6 (11) | 0 | 0 | 0 |
Headache | 6 (11) | 0 | 0 | 0 |
Muscle spasms | 6 (11) | 0 | 0 | 0 |
Myalgia | 6 (11) | 0 | 0 | 0 |
Productive cough | 6 (11) | 0 | 0 | 0 |
Vertigo | 6 (11) | 0 | 0 | 0 |
Hyperkeratosis | 5 (9) | 1 (2) | 0 | 0 |
Weight increased | 5 (9) | 1 (2) | 0 | 0 |
Back pain | 4 (7) | 0 | 1 (2) | 0 |
Hemoptysis | 4 (7) | 1 (2) | 0 | 0 |
Aspartate aminotransferase increased | 3 (5) | 1 (2) | 0 | 0 |
Blood creatinine increased | 3 (5) | 1 (2) | 0 | 0 |
Hypophosphatemia | 3 (5) | 1 (2) | 0 | 0 |
Thrombocytopenia | 3 (5) | 1 (2) | 0 | 0 |
Hyponatremia | 2 (4) | 3 (5) | 1 (2) | 0 |
Leukopenia | 2 (4) | 2 (4) | 0 | 0 |
Alanine aminotransferase increased | 2 (4) | 1 (2) | 0 | 0 |
Dehydration | 1 (2) | 2 (4) | 0 | 0 |
Hypertension | 1 (2) | 2 (4) | 0 | 0 |
Amylase increased | 1 (2) | 1 (2) | 0 | 0 |
Basal cell carcinoma | 1 (2) | 1 (2) | 0 | 0 |
Erythema nodosum | 1 (2) | 1 (2) | 0 | 0 |
Hematuria | 1 (2) | 1 (2) | 0 | 0 |
Peripheral neuropathy | 1 (2) | 1 (2) | 0 | 0 |
Pain | 1 (2) | 1 (2) | 0 | 0 |
Pulmonary embolism | 1 (2) | 1 (2) | 0 | 0 |
Tubulointerstitial nephritis | 1 (2) | 1 (2) | 0 | 0 |
Visual impairment | 1 (2) | 1 (2) | 0 | 0 |
Gamma-glutamyltransferase increased | 0 | 1 (2) | 1 (2) | 0 |
Hypercalcemia | 0 | 2 (4) | 0 | 0 |
Respiratory distress | 0 | 1 (2) | 0 | 1 (2) |
Squamous cell carcinoma of skin | 0 | 2 (4) | 0 | 0 |
C-reactive protein increased | 0 | 1 (2) | 0 | 0 |
Cholecystitis acute | 0 | 1 (2) | 0 | 0 |
Coronary artery stenosis | 0 | 1 (2) | 0 | 0 |
Febrile neutropenia | 0 | 1 (2) | 0 | 0 |
Hepatocellular carcinoma | 0 | 1 (2) | 0 | 0 |
Hip fracture | 0 | 1 (2) | 0 | 0 |
Incisional hernia | 0 | 1 (2) | 0 | 0 |
Intestinal obstruction | 0 | 1 (2) | 0 | 0 |
Legionella infection | 0 | 0 | 1 (2) | 0 |
Lung neoplasm malignanta | 0 | 1 (2) | 0 | 0 |
Neoplasm progressionb | 0 | 0 | 0 | 1 (2) |
Pancytopenia | 0 | 1 (2) | 0 | 0 |
Pleural effusion | 0 | 1 (2) | 0 | 0 |
Pyelonephritis | 0 | 1 (2) | 0 | 0 |
Quadriplegia | 0 | 1 (2) | 0 | 0 |
Renal failure | 0 | 1 (2) | 0 | 0 |
Retroperitoneal hemorrhage | 0 | 0 | 0 | 1 (2) |
Subarachnoid hemorrhage | 0 | 0 | 0 | 1 (2) |
Ventricular fibrillation | 0 | 0 | 1 (2) | 0 |
One patient had a lung metastasis that did not respond to therapy, was biopsied, and was determined to have a KRAS mutation. This was reported as an AE by the investigator.
One patient was determined by the investigator to have progression that was more severe than typical progression. According to study protocol this can be documented as an AE.
Patients with multiple events in the same category are counted only once in that category. Patients with events in more than 1 category are counted once in each of those categories.