Table 2 provides common (≥10%) treatment-emergent laboratory abnormalities.

After an interim analysis, the study was unblinded, and patients on the placebo arm were given the opportunity to receive open-label SUTENT treatment [see Clinical Studies (14.1)]. For 241 patients randomized to the SUTENT arm, including 139 who received SUTENT in both the double-blind and open-label treatment phases, the median duration of SUTENT treatment was 6 cycles (mean 8.5, range 1 – 44). For the 255 patients who ultimately received open-label SUTENT treatment, median duration of study treatment was 6 cycles (mean 7.8, range 1 – 37) from the time of the unblinding. A total of 118 patients (46%) required dosing interruptions, and a total of 72 patients (28%) required dose reductions. The incidence of treatment-emergent adverse reactions resulting in permanent discontinuation was 20%. The most common Grade 3 or 4 treatment-related adverse reactions experienced by patients receiving SUTENT in the open-label treatment phase were fatigue (10%), hypertension (8%), asthenia (5%), diarrhea (5%), hand-foot syndrome (5%), nausea (4%), abdominal pain (3%), anorexia (3%), mucositis (2%), vomiting (2%), and hypothyroidism (2%).

Table 1. Adverse Reactions Reported in Study A in at Least 10% of GIST Patients who Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in Patients Given PlaceboCommon Terminology Criteria for Adverse Events (CTCAE), Version 3.0  Adverse Reaction,
n (%) GIST
SUTENT (n=202) Placebo (n=102)
All Grades Grade 3/4 All Grades Grade 3/4
Any   114 (56)  52 (51)
Gastrointestinal     
  Diarrhea 81 (40) 9 (4) 27 (27) 0 (0)
  Mucositis/stomatitis 58 (29) 2 (1) 18 (18) 2 (2)
  Constipation 41 (20) 0 (0) 14 (14) 2 (2)
Cardiac
  Hypertension
31 (15)
9 (4)
11 (11)
0 (0)
Dermatology     
  Skin discoloration 61 (30) 0 (0) 23 (23) 0 (0)
  Rash 28 (14) 2 (1) 9 (9) 0 (0)
  Hand-foot syndrome 28 (14) 9 (4) 10 (10) 3 (3)
Neurology     
  Altered taste 42 (21) 0 (0) 12 (12) 0 (0)
Musculoskeletal     
  Myalgia/limb pain 28 (14) 1 (1) 9 (9) 1 (1)
Metabolism/Nutrition     
  AnorexiaIncludes decreased appetite  67 (33) 1 (1) 30 (29) 5 (5)
  Asthenia 45 (22) 10 (5) 11 (11) 3 (3)
Table 2. Laboratory Abnormalities Reported in Study A in at Least 10% of GIST Patients Who Received SUTENT or Placebo in the Double-Blind Treatment PhaseCommon Terminology Criteria for Adverse Events (CTCAE), Version 3.0  Laboratory
Parameter, n (%) GIST
SUTENT (n=202) Placebo (n=102)
All Grades  Grade 3/4 Grade 4 laboratory abnormalities in patients on SUTENT included alkaline phosphatase (1%), lipase (2%), creatinine (1%), potassium decreased (1%), neutrophils (2%), hemoglobin (2%), and platelets (1%).  All Grades  Grade 3/4 Grade 4 laboratory abnormalities in patients on placebo included amylase (1%), lipase (1%), and hemoglobin (2%). 
LVEF=Left ventricular ejection fraction
Any   68 (34)  22 (22)
Gastrointestinal