Detailed safety information is available for a total of 353 patients with hormone-refractory prostate cancer treated with Novantrone, including 274 patients who received Novantrone in combination with corticosteroids.

Table 7 summarizes adverse reactions of all grades occurring in ≥ 5% of patients in Trial CCI-NOV22.

Table 7 Adverse Events of Any Intensity Occurring in ≥ 5% of Patients Trial CCI-NOV22  N + P P
 (n = 80) (n = 81)
Event % %
N = Novantrone, P = prednisone.
Nausea 61 35
Fatigue 39 14
Alopecia 29 0
Anorexia 25 6
Constipation 16 14
Dyspnea 11 5
Nail bed changes 11 0
Edema 10 4
Systemic infection 10 7
Mucositis 10 0
UTI 9 4
Emesis 9 5
Pain 8 9
Fever 6 3
Hemorrhage/bruise 6 1
Anemia 5 3
Cough 5 0
Decreased LVEF 5 0
Anxiety/depression 5 3
Dyspepsia 5 6
Skin infection 5 3
Blurred vision 3 5
N = Novantrone, P = prednisone.
No nonhematologic adverse events of Grade 3/4 were seen in > 5% of patients.

Table 8 summarizes adverse events of all grades occurring in ≥ 5% of patients in Trial CALGB 9182.

Table 8 Adverse Events of Any Intensity Occurring in ≥ 5 % of Patients Trial CALGB 9182  N + H     H
 (n = 112)     (n = 113)
Event n %     n %
N= Novantrone, H= hydrocortisone
Decreased WBC 96 87  4 4
Abnormal granulocytes/bands 88 79  3 3
Decreased hemoglobin 83 75  42 39
Abnormal lymphocytes count 78 72  27 25
Pain 45 41  44 39
Abnormal platelet count 43 39  8 7
Abnormal alkaline phosphatase 41 37  42 38
Malaise/fatigue 37 34  16 14
Hyperglycemia 33 31  32 30
Edema 31 30  15 14
Nausea 28 26  9 8
Anorexia 24 22  16 14
Abnormal BUN 24 22  22 20
Abnormal Transaminase 22 20  16 14
Alopecia 20 20  1 1
Abnormal Cardiac function 19 18  0 0
Infection 18 17  4 4
Weight loss 18 17  13 12
Dyspnea 16 15  9 8
Diarrhea 16 14  4 4
F