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TOP
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NOVANTRONE(十四)
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Nausea |
20 |
55 |
76 |
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Alopecia |
31 |
38 |
61 |
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Menstrual disorder * |
26 |
51 |
61 |
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Amenorrhea * |
3 |
28 |
43 |
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Upper respiratory tract infection |
52 |
51 |
53 |
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Urinary tract infection |
13 |
29 |
32 |
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Stomatitis |
8 |
15 |
19 |
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Arrhythmia |
8 |
6 |
18 |
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Diarrhea |
11 |
25 |
16 |
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Urine abnormal |
6 |
5 |
11 |
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ECG abnormal |
3 |
5 |
11 |
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Constipation |
6 |
14 |
10 |
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Back pain |
5 |
6 |
8 |
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Sinusitis |
2 |
3 |
6 |
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Headache |
5 |
6 |
6 |
The proportion of patients experiencing any infection during Study 1 was 67% for the placebo group, 85% for the 5 mg/m2 group, and 81% for the 12 mg/m2 group. However, few of these infections required hospitalization: one placebo patient (tonsillitis), three 5 mg/m2 patients (enteritis, urinary tract infection, viral infection), and four 12 mg/m2 patients (tonsillitis, urinary tract infection [two], endometritis).
Table 4b summarizes laboratory abnormalities that occurred in ≥ 5% of patients in either NOVANTRONE dose group, and that were numerically more frequent than in the placebo group.
Table 4b Laboratory Abnormalities Occurring in ≥ 5% of Patients* on Either Dose of NOVANTRONE and That Were More Frequent Than in the Placebo Group Study 1
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Percent of Patients |
|
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Placebo |
5 mg/m2
NOVANTRONE |
12 mg/m2
NOVANTRONE |
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Event |
(N = 64) |
(N = 65) |
(N = 62) |
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* Assessed using World Health Organization (WHO) toxicity criteria. |
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a. < 4000 cells/mm3 |
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b. < 2000 cells/mm3 |
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Leukopenia a |
0 |
9 |
19 |
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Gamma-GT increased |
3 |
3 |
15 |
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SGOT increased |
8 |
9 |
8 |
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Granulocytopenia b |
2 |
6 |
6 |
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Anemia |
2 |
9 |
6 |
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SGPT increased |
3 |
6 |
5 |
There was no difference among treatment groups in the incidence or severity of hemorrhagic events.
In Study 2, NOVANTRONE was administered once a month. Clinical adverse events most frequently reported in the NOVANTRONE group included amenorrhea (53% of female patients), alopecia (33% of patients), nausea (29% of patients), and asthenia (24% of patients). Tables 5a and 5b respectively summarize adverse events and laboratory abnormalities occurring in > 5% of patients in the NOVANTRONE group and numerically more frequent than in the c |
