The potentially serious adverse events relating to left ventricular dysfunction, hemorrhage, hypertension, and adrenal function are discussed in Section 5 WARNINGS AND PRECAUTIONS. Other all-causality adverse events occurring in GIST and MRCC studies are described below.

6.2 Adverse Events in GIST Study A
Median duration of blinded study treatment was two cycles for patients on SUTENT (mean 3.0, range 1–9) and one cycle (mean 1.8, range 1–6) for patients on placebo. Dose reductions occurred in 23 patients (11%) on SUTENTand none on placebo. Dose interruptions occurred in 59 patients (29%) on SUTENT and 31 patients (30%) on placebo. The rates of treatment-emergent, non-fatal adverse events resulting in permanent discontinuation were 7% and 6% in the SUTENT and placebo groups, respectively.

Most treatment-emergent adverse events in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse events were reported in 56% vs. 51% of patients on SUTENT versus placebo, respectively. Diarrhea, hypertension, bleeding, mucositis, skin abnormalities, and altered taste were more common in patients receiving SUTENT. Table 1 compares the incidence of common (>10%) treatment-emergent adverse events for patients receiving SUTENT versus those on placebo.

Oral pain other than mucositis/stomatitis occurred in 12 patients (6%) on SUTENT versus 3 (3%) on placebo. Hair color changes occurred in 15 patients (7%) on SUTENT versus 4 (4%) on placebo. Alopecia was observed in 10 patients (5%) on SUTENT versus 2 (2%) on placebo.

Table 1. Treatment-Emergent Adverse Events Reported in at Least 10% of GIST Patients Who Received SUTENT or Placebo in Study A *   GIST
 SUTENT (n=202) Placebo (n=102)
Adverse Event, n (%) All Grades Grade 3/4† All Grades Grade 3/4‡
*
Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0
†
Grade 4 AEs in patients on SUTENT included abdominal pain (2%) and bleeding (2%).
‡
Grade 4 AEs in patients on placebo included fatigue (3%), mucositis (1%), vomiting (1%), abdominal pain (3%), back pain (1%), and bone pain (1%).
§
Includes abdominal quadrant, gastric, hypochondrial, abdominal, flank, and cancer-related pain
¶
Includes decreased appetite 
Any  114 (56)  52 (51)
Constitutional    
  Fatigue 84 (42) 17 (8) 48 (47) 8 (8)
  Fever 36 (18) 3 (2) 17 (17) 1 (1)
Gastrointestinal    
  Diarrhea 81 (40) 9 (4) 27 (27) 0 (0)
  Nausea 63 (31) 3 (2) 33 (32) 5 (5)
  Mucositis/stomatitis 58 (29) 2 (1) 18 (18) 2 (2)
  Vomiting 49 (24) 4 (2) 24 (24) 3 (3)
  Constipation 41 (20) 0 (0) 14 (14) 2 (2)
  Abdominal pain§ 67 (33) 22 (11) 39 (38) 12 (12)
Cardiac    
  Hypertension 31 (15) 9 (4) 11 (11) 0 (0)
Dermatology    
  Rash 28 (14) 2 (1) 9 (9) 0 (0)
  Skin discoloration 61 (30) 0 (0) 23 (23) 0 (0)
  Hand-foot syndrome 28 (14) 9 (4) 10 (10) 3 (3)
Neurology    
  Altered taste 42 (21) 0 (0) 12 (12) 0 (0)