Table 4.

Incidence of treatment-emergent grade 3 or 4 adverse events

CategoryGrade100 mg bid (n = 3), n (%)200 mg bid (n = 3), n (%)400 mg bid (n = 4), n (%)600 mg bid (n = 6), n (%)800 mg bid (n = 3), n (%)Total (n = 19), n (%)
Any category32 (67)0 (0)3 (75)4 (67)3 (100)12 (63)
40 (0)1 (33)1 (25)0 (0)0 (0)2 (11)
Blood/bone marrow (hemoglobin)30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Cardiovascular
    Hypertension30 (0)0 (0)0 (0)0 (0)1 (33)1 (5)
    Thrombosis/embolism30 (0)1 (33)1 (25)0 (0)0 (0)2 (11)
    Edema30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Coagulation (prothrombin time)30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Flu-like symptoms
    Fatigue30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
40 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Gastrointestinal
    Anorexia30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
    Ascites30 (0)0 (0)0 (0)2 (33)0 (0)2 (11)
    Constipation30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
    Dehydration30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
    Diarrhea (patients with and without colostomy)30 (0)0 (0)2 (50)0 (0)0 (0)2 (11)
    Nausea30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
    Vomiting30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Genitourinary
    Creatinine30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
    Ureteral obstruction30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
Hepatic
    Hypoalbumenia30 (0)0 (0)1 (25)1 (17)0 (0)2 (11)
    Alkaline phosphatase31 (33)0 (0)1 (25)2 (33)0 (0)4 (21)
Infection (without neutropenia)30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Musculoskeletal (muscle weakness)30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
Metabolic
    Hypocalcemia40 (0)1 (33)0 (0)0 (0)0 (0)1 (5)
    Hyponatremia30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Neurologic (depressed level of consciousness)30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
40 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
Pain
    Abdominal cramping30 (0)0 (0)1 (25)0 (0)0 (0)1 (5)
    Pleuritic pain31 (33)0 (0)0 (0)0 (0)0 (0)1 (5)
Pulmonary
    Pleural effusion30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
    Hypoxia30 (0)0 (0)0 (0)1 (17)0 (0)1 (5)
    Dyspnea30 (0)0 (0)0 (0)0 (0)1 (33)1 (5)
Skin (rash/desquamation)30 (0)0 (0)0 (0)0 (0)2 (67)2 (11)