Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the patients treated with Gleevec are shown in Table 9.

Overall the incidence of all grades of adverse reactions and the incidence of severe adverse reactions (CTC Grade 3 and above) were similar between the two treatment arms except for edema, which was reported more frequently in the 800 mg group.

Table 9 Number (%) of Patients with Adverse Reactions where Frequency is ≥10% in any One Group (Full Analysis Set) in the Phase 3 Unresectable and/or Malignant Metastatic GIST Clinical Trials Reported or Specified Term Imatinib 400 mg
N=818 Imatinib 800 mg
N=822
 All Grades % Grades 3/4/5
% All Grades % Grades 3/4/5
%
Edema 76.7 9.0 86.1 13.1
Fatigue/lethargy, malaise, asthenia 69.3 11.7 74.9 12.2
Nausea 58.1 9.0 64.5 7.8
Abdominal pain/cramping 57.2 13.8 55.2 11.8
Diarrhea 56.2 8.1 58.2 8.6
Rash/desquamation 38.1 7.6 49.8 8.9
Vomiting 37.4 9.2 40.6 7.5
Myalgia 32.2 5.6 30.2 3.8
Anemia 32.0 4.9 34.8 6.4
Anorexia 31.1 6.6 35.8 4.7
Other GI toxicity 25.2 8.1 28.1 6.6
Headache 22.0 5.7 19.7 3.6
Other pain (excluding tumor related pain) 20.4 5.9 20.8 5.0
Other dermatology /skin toxicity 17.6 5.9 20.1 5.7
Leukopenia 17.0 0.7 19.6 1.6
Other constitutional symptoms 16.7 6.4 15.2 4.4
Cough 16.1 4.5 14.5 3.2
Infection (without neutropenia) 15.5 6.6 16.5 5.6
Pruritus 15.4 5.4 18.9 4.3
Other neurological toxicity 15.0 6.4 15.2 4.9
Constipation 14.8 5.1 14.4 4.1
Other renal/genitourinary toxicity 14.2 6.5 13.6 5.2
Arthralgia (joint pain) 13.6 4.8 12.3 3.0
Dyspnea (shortness of breath) 13.6 6.8 14.2 5.6
Fever in absence of neutropenia (ANC<1.0 x 109/L) 13.2 4.9 12.9 3.4
Sweating 12.7 4.6 8.5 2.8
Other hemorrhage 12.3 6.7 13.3 6.1
Weight gain 12.0 1.0 10.6 0.6
Alopecia 11.9 4.3 14.8 3.2
Dyspepsia/heartburn 11.5 0.6 10.9 0.5
Neutropenia/ granulocytopenia 11.5 3.1 16.1 4.1
Rigors/chills 11.0 4.6 10.2 3.0
Dizziness/ lightheadedness 11.0 4.8 10.0 2.8
Creatinine increase 10.8 0.4 10.1 0.6
Flatulence 10.0 0.2 10.1 0.1
Stomatitis/pharyngitis (oral/pharyngeal mucositis) 9.2 5.4 10.0 4.3
Lymphopenia 6.0 0.7 10.1 1.9

Clinically relevant or severe abnormalities of routine hematologic or biochemistry laboratory values were not reported or eva luated in the Phase 3 GIST trials. Severe abnormal laboratory values reported in the Phase 2 GIST trial are presented in Table 10.

Table 10 Laboratory Abnormalities in the Phase 2 Unresectable and/or Malignant Metastatic GIST Trial  400 mg
(n=73) 600 mg
(n=74)
 % %
CTC Grades1 Grade 3 Grade 4 Grade 3 Grade 4
Hematology Parameters    
− Anemia 3 0 8 1
− Thrombocytopenia 0 0 1 0
− Neutropenia 7 3 8 3
Biochemistry Parameters    
− Elevated Creatinine 0 0 3 0
− Reduced Albumin 3 0 4 0
− Elevated Bilirubin 1 0 1 3
− Elevated Alkaline Phosphatase 0 0 3 0
− Elevated SGOT (AST) 4 0 3 3
− Elevated SGPT (ALT) 6 0 7 1
1CTC Grades: neutropenia (Grade 3 ≥0.5-1.0 x 109/L, Grade 4 <0.5 x 109/L), thrombocytopenia (Grade 3 ≥10 - 50 x 109/L, Grade 4 <10 x 109/L), anemia (Grade 3 &