|
30
|
30 |
|
34 |
35 |
|
Seizures |
4 |
4 |
|
2 |
8 |
|
Headache |
10 |
9 |
|
13 |
8 |
|
Eye |
7 |
6 |
|
2 |
4 |
|
Conjunctivitis |
5 |
1 |
|
0 |
0 |
Hormone-Refractory Prostate Cancer
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 |
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 |
|
