Adverse reactions, regardless of relationship to study drug, that were reported in at least 5% of the patients treated with Gleevec are shown in Table 11.

Table 11: Adverse Reactions Reported in the Adjuvant GIST Trial (≥5% of Gleevec Treated Patients)(1)  All CTC Grades CTC Grade 3 and above
 Gleevec
(n=337) Placebo
(n=345) Gleevec
(n=337) Placebo
(n=345)
Preferred Term % % % %
Diarrhea 59.3 29.3 3.0 1.4
Fatigue 57.0 40.9 2.1 1.2
Nausea 53.1 27.8 2.4 1.2
Periorbital Edema 47.2 14.5 1.2 0
Hemoglobin Decreased 46.9 27.0 0.6 0
Peripheral Edema 26.7 14.8 0.3 0
Rash (Exfoliative) 26.1 12.8 2.7 0
Vomiting 25.5 13.9 2.4 0.6
Abdominal Pain 21.1 22.3 3.0 1.4
Headache 19.3 20.3 0.6 0
Dyspepsia 17.2 13.0 0.9 0
Anorexia 16.9 8.7 0.3 0
Weight Increased 16.9 11.6 0.3 0
Liver enzymes (ALT) Increased 16.6 13.0 2.7 0
Muscle spasms 16.3 3.3 0 0
Neutrophil Count Decreased 16.0 6.1 3.3 0.9
Arthralgia 15.1 14.5 0 0.3
White Blood Cell Count Decreased 14.5 4.3 0.6 0.3
Constipation 12.8 17.7 0 0.3
Dizziness 12.5 10.7 0 0.3
Liver Enzymes (AST) Increased 12.2 7.5 2.1 0
Myalgia 12.2 11.6 0 0.3
Blood Creatinine Increased 11.6 5.8 0 0.3
Cough 11.0 11.3 0 0
Pruritus 11.0 7.8 0.9 0
Weight Decreased 10.1 5.2 0 0
Hyperglycemia 9.8 11.3 0.6 1.7
Insomnia 9.8 7.2 0.9 0
Lacrimation Increased 9.8 3.8 0 0
Alopecia 9.5 6.7 0 0
Flatulence 8.9 9.6 0 0
Rash 8.9 5.2 0.9 0
Abdominal Distension 7.4 6.4 0.3 0.3
Back Pain 7.4 8.1 0.6 0
Pain in Extremity 7.4 7.2 0.3 0
Hypokalemia 7.1 2.0 0.9 0.6
Depression 6.8 6.4 0.9 0.6
Facial Edema 6.8 1.2 0.3 0
Blood Alkaline Phosphatase Increased 6.5 7.5 0 0
Dry skin 6.5 5.2 0 0
Dysgeusia 6.5 2.9 0 0
Abdominal Pain Upper 6.2 6.4 0.3 0
Neuropathy Peripheral 5.9 6.4 0 0
Hypocalcemia 5.6 1.7 0.3 0
Leukopenia 5.0 2.6 0.3 0
Platelet Count Decreased  5.0 3.5 0 0
Stomatitis 5.0 1.7 0.6 0
Upper Respiratory Tract Infection 5.0 3.5 0 0
Vision Blurred 5.0 2.3 0 0
(1)All adverse reactions occurring in ≥5% of patients are listed regardless of suspected relationship to treatment.
A patient with multiple occurrences of an adverse reaction is counted only once in the adverse reaction category.

6.12 Additional Data from Multiple Clinical Trials
The following adverse reactions have been reported during clinical trials of Gleevec.

Cardiac Disorders:
Estimated 0.1%-1%: congestive cardiac failure, tachycardia, palpitations, pulmonary edema,

Estimated 0.01%-0.1%: arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion

Vascular Disorders:

Estimated 1%-10%: flushing, hemorrhage

Estimated 0.1%-1%: hypertension, hypotension, peripheral coldness, Raynauds phenomenon, hematoma,

Clinical Laboratory Tests:

Estimated 0.1%-1%: blood CPK increased, blood LDH increased,

Estimated 0.01%-0.1%: blood amylase increased

Dermatologic:

Estimated 1%-10%: dry skin, alopecia, face edema, erythema, photosensitivity reaction,

Estimated 0.1%-1%: exfoliative dermatitis,