Table 2 provides common (≥10%) treatment-emergent laboratory abnormalities. Grade 3 or 4 treatment-emergent laboratory abnormalities were observed in 68 (34%) versus 22 (22%) patients on SUTENT and placebo, respectively. Elevated liver function tests, pancreatic enzymes, and creatinine were more common in patients treated with SUTENT than placebo. Decreased LVEF and myelosuppression were also more common with SUTENT treatment. Treatment-emergent electrolyte disturbances of all types were more common in patients on SUTENT than on placebo, including hyperkalemia (6% vs. 4%), hypokalemia (12% vs. 4%), hypernatremia (10% vs. 4%), hyponatremia (6% vs. 1%), and hypophosphatemia (9% vs. 0%). Three SUTENT patients (1.5%) had Grade 3 hypophosphatemia. Acquired hypothyroidism was noted in 8 patients (4%) on SUTENT versus 1 (1%) on placebo.

Table 2. Treatment-Emergent Laboratory Abnormalities (≥10%) from Study A *   GIST
Adverse Event, n (%) SUTENT (n=202) Placebo (n=102)
 All Grades Grade 3/4† All Grades Grade 3/4‡
LVEF=Left ventricular ejection fraction
*
Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0
†
Grade 4 AEs in patients on SUTENT included alkaline phosphatase (1%), lipase (2%), creatinine (1%), hypokalemia (1%), neutropenia (2%), anemia (2%), and thrombocytopenia (1%).
‡
Grade 4 AEs in patients on placebo included amylase (1%), lipase (1%), anemia (2%), and thrombocytopenia (1%). 
Any  68 (34)  22 (22)
Gastrointestinal    
  AST / ALT 78 (39) 3 (2) 23 (23) 1 (1)
  Alkaline phosphatase 48 (24) 7 (4) 21 (21) 4 (4)
  Total bilirubin 32 (16) 2 (1) 8 (8) 0 (0)
  Indirect bilirubin 20 (10) 0 (0) 4 (4) 0 (0)
  Amylase 35 (17) 10 (5) 12 (12) 3 (3)
  Lipase 50 (25) 20 (10) 17 (17) 7 (7)
Cardiac    
  Decreased LVEF 22 (11) 2 (1) 3 (3) 0 (0)
Renal / Metabolic    
  Creatinine 25 (12) 1 (1) 7 (7) 0 (0)
  Hypokalemia 24 (12) 1 (1) 4 (4) 0 (0)
  Hypernatremia 20 (10) 0 (0) 4 (4) 1 (1)
  Uric acid 31 (15) 16 (8) 16 (16) 8 (8)
Hematology    
  Neutropenia 107 (53) 20 (10) 4 (4) 0 (0)
  Lymphopenia 76 (38) 0 (0) 16 (16) 0 (0)
  Anemia 52 (26) 6 (3) 22 (22) 2 (2)
  Thrombocytopenia 76 (38) 10 (5) 4 (4) 0 (0)

6.3 Adverse Events in MRCC Studies
The as-treated patient population for the interim safety analysis of the treatment-naive MRCC study included 735 patients, 375 randomized to SUTENT and 360 randomized to IFN-α. The median duration of treatment was 5.6 months (range: 0.4–15.6) for SUTENT treatment and 4.1 months (range: 0.1–13.7) on IFN-α treatment. Dose reductions occurred in 121 patients (32%) on SUTENTand 77