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. Author manuscript; available in PMC: 2016 Aug 22.
Published in final edited form as: Lancet Oncol. 2016 Jun 6;17(7):984–993. doi: 10.1016/S1470-2045(16)30146-2

Table 3.

Common (>10% all grades or any ≥ grade 3) adverse events in ≥ second-line patients (n=57)

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
a

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.

b

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.