nbsp;0
Alkaline Phosphatase
71
16
0
64
10
3
Bilirubin
16
2
2
25
6
3
Renal
Proteinuria
10
0
0
2
0
0
Hematuria
13
0
0
0
0
0
BUN
8
0
0
10
0
0
Creatinine
2
0
0
0
0
0
Non–laboratory¶
Nausea and Vomiting
64
10
3
58
5
0
Pain
10
2
0
7
0
0
Fever
30
0
0
16
0
0
Rash
24
0
0
13
0
0
Dyspnea
6
0
0
3
0
0
Constipation
10
3
0
11
2
0
Diarrhea
24
2
0
31
5
0
Hemorrhage
0
0
0
2
0
0
Infection
8
0
0
3
2
0
Alopecia
18
0
0
16
0
0
Stomatitis
14
0
0
15
0
0
Somnolence
5
2
0
7
2
0
Paresthesias
2
0
0
2
0
0
Grade based on criteria from the World Health Organization (WHO).
N=58–63; all Gemzar patients with laboratory or non–laboratory data.
N=61–63; all 5–FU patients with laboratory or non–laboratory data.
Regardless of causality.
Non–laboratory events were graded only if assessed to be possibly drug–related.
Hematologic— In studies in pancreatic cancer myelosuppression is the dose–limiting toxicity with Gemzar, but <1% of patients discontinued therapy for either anemia, leukopenia, or thrombocytopenia. Red blood cell transfusions were required by 19% of patients. The incidence of sepsis was less than 1%. Petechiae or mild blood loss (hemorrhage), from any cause, was reported in 16% of patients; less than 1% of patients required platelet transfusions. Patients should be monitored for myelosuppression during Gemzar therapy and dosage modified or suspended according to the degree of hematologic toxicity (see DOSAGE AND ADMINISTRATION).
Gastrointestinal— Nausea and vomiting were commonly reported (69%) but were usually of mild to moderate severity. Severe nausea and vomiting (WHO Grade 3/4) occurred in <15% of patients. Diarrhea was reported by 19% of patients, and stomatitis by 11% of patients.
Hepatic— In clinical trials, Gemzar was associated with transient elevations of one or both serum transaminases in approximately 70% of patients, but there was no evidence of increasing hepatic toxicity with either longer duration of exposure to Gemzar or with greater total cumulative dose. Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving Gemzar alone or in combination with other potentially hepatotoxic drugs (see Hepatic under |
