;22
2
<1
Diarrhea
20
3
0
13
2
0
Anorexia
17
0
0
12
<1
0
Neuropathy–motor
15
2
<1
10
<1
0
Stomatitis/pharyngitis
13
1
<1
8
<1
0
Fever
13
<1
0
3
0
0
Constipation
11
<1
0
12
0
0
Bone pain
11
2
0
10
<1
0
Pain–other
11
<1
0
8
<1
0
Rash/desquamation
11
<1
<1
5
0
0
Grade based on Common Toxicity Criteria (CTC) Version 2.0 (all grades ≥10%).
Regardless of causality.
Non–laboratory events were graded only if assessed to be possibly drug–related.
The following are the clinically relevant adverse events that occurred in >1% and <10% (all grades) of patients on either arm. In parentheses are the incidences of Grade 3 and 4 adverse events (Gemzar plus paclitaxel versus paclitaxel): febrile neutropenia (5.0% versus 1.2%), infection (0.8% versus 0.8%), dyspnea (1.9% versus 0), and allergic reaction/hypersensitivity (0 versus 0.8%).
No differences in the incidence of laboratory and non–laboratory events were observed in patients 65 years or older, as compared to patients younger than 65.
Combination Use in Ovarian Cancer: In the Gemzar plus carboplatin versus carboplatin study, dose reductions occurred with 10.4% of Gemzar injections and 1.8% of carboplatin injections on the combination arm, versus 3.8% on the carboplatin alone arm. On the combination arm, 13.7% of Gemzar doses were omitted and 0.2% of carboplatin doses were omitted, compared to 0% of carboplatin doses on the carboplatin alone arm. There were no differences in discontinuations due to adverse events between arms (10.9% versus 9.8%, respectively).
Table 12 presents the adverse events (all grades) occurring in ≥10% of patients in the ovarian cancer study.
Table 12: Adverse Events From Comparative Trial of Gemzar Plus Carboplatin Versus Single–Agent Carboplatin in Ovarian Cancer* CTC Grades (% incidence)
Grade based on Common Toxicity Criteria (CTC) Version 2.0 (all grades ≥10%).
Regardless of causality.
Percent of patients receiving transfusions. Transfusions are not CTC–graded events. Blood transfusions included both packed red blood cells and whole blood.
Gemzar plus Carboplatin
(N=175)
Carboplatin
(N=174)
All Grades
Grade 3
Grade 4
All Grades
Grade 3
Grade 4
Laboratory†
Hematologic
Neutropenia
90
42
29
58
11
1
Anemia
86
22
6
75
9
2
Leukopenia
86
48
5
70
6
<1
Thrombocytopenia
78
30
5
57
10
1
RBC Transfusions‡
38
15
Platelet Transfusions‡
9
3
|
