s due to pancytopenia/marrow hypoplasia. Two (2%) cases of pancytopenia/ marrow hypoplasia were fatal.
Anemia: Forty-four (47%) patients had one or more episodes of new onset NCI-CTC Grade 3 or 4 anemia. Sixty-two (67%) patients required RBC transfusions. In addition, erythropoietin use was reported in nineteen (20%) patients. Autoimmune hemolytic anemia secondary to Campath therapy was reported in 1% of patients. Positive Coombs test without hemolysis was reported in 2%. (See BOXED WARNING.)
Neutropenia: Sixty-five (70%) patients had one or more episodes of NCI-CTC Grade 3 or 4 neutropenia. Median duration of Grade 3 or 4 neutropenia was 28 days (range: 2 – 165 days). (See Infections.)
Thrombocytopenia: Forty-eight (52%) patients had one or more episodes of new onset Grade 3 or 4 thrombocytopenia. Median duration of thrombocytopenia was 21 days (range: 2 – 165 days). Thirty-five (38%) patients required platelet transfusions for management of thrombocytopenia. Autoimmune thrombocytopenia was reported in 2% of patients with one fatal case of Campath-related autoimmune thrombocytopenia. (See BOXED WARNING.)
Lymphopenia: The median CD4+ count at 4 weeks after initiation of Campath therapy was 2 (two)/mL, at 2 months after discontinuation of Campath therapy, 207/mL, and 6 months after discontinuation, 470/mL. The pattern of change in median CD8+ lymphocyte counts was similar to that of CD4+ cells. In some patients treated with Campath, CD4+ and CD8+ lymphocyte counts had not returned to baseline levels at longer than 1 year post therapy.
Table 2: Adverse Events in > 5% of the B-CLL Study PopulationDuring Treatment or Within 30 Days (N = 149)
Adverse Event: B-CLL STUDIES(N = 149)
ANY Grade(%) Grade 3 or 4(%)
Body As A Whole
Rigors 86 16
Fever 85 19
Fatigue 34 5
Pain, Skeletal Pain 24 2
Anorexia 20 3
Asthenia 13 4
Edema, Peripheral Edema 13 1
Back Pain 10 3
Chest Pain 10 1
Malaise 9 1
Temperature Change Sensation 5 --
Cardiovascular Disorders, General
Hypotension 32 5
Hypertension 11 2
Heart Rate & Rhythm Disorders
Tachycardia, SVT 11 3
Central & Peripheral Nervous System Disorders
Headache 24 1
Dysthesias 15 --
Dizziness 12 1
Tremor 7 --
Gastrointestinal Disorders
Nausea 54 2
Vomiting 41 4
Diarrhea 22 1
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