;Non–laboratory†
Nausea
69
6
0
61
3
0
Alopecia
49
0
0
17
0
0
Vomiting
46
6
0
36
2
<1
Constipation
42
6
1
37
3
0
Fatigue
40
3
<1
32
5
0
Neuropathy–sensory
29
1
0
27
2
0
Diarrhea
25
3
0
14
<1
0
Stomatitis/pharyngitis
22
<1
0
13
0
0
Anorexia
16
1
0
13
0
0
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.
In addition to blood product transfusions as listed in Table 12, myelosuppression was also managed with hematopoetic agents. These agents were administered more frequently with combination therapy than with monotherapy (granulocyte growth factors: 23.6% and 10.1%, respectively; erythropoetic agents: 7.3% and 3.9%, respectively).
The following are the clinically relevant adverse events, regardless of causality, 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 carboplatin versus carboplatin): AST or ALT elevation (0 versus 1.2%), dyspnea (3.4% versus 2.9%), febrile neutropenia (1.1% versus 0), hemorrhagic event (2.3% versus 1.1%), hypersensitivity reaction (2.3% versus 2.9%), motor neuropathy (1.1% versus 0.6%), and rash/desquamation (0.6% versus 0).
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.
Post–marketing experience: The following adverse events have been identified during post–approval use of Gemzar. These events have occurred after Gemzar single–agent use and Gemzar in combination with other cytotoxic agents. Decisions to include these events are based on the seriousness of the event, frequency of reporting, or potential causal connection to Gemzar.
Cardiovascular— Congestive heart failure and myocardial infarction have been reported very rarely with the use of Gemzar. Arrhythmias, predominantly supraventricular in nature, have been reported very rarely.
Vascular Disorders— Clinical signs of peripheral vasculitis and gangrene have been reported very rarely.
Skin— Cellulitis and non–serious injection site reactions in the absence of extravasation have been rarely reported. Severe skin reactions, including desquamation and bullous skin eruptions, have been reported very rarely.
Hepatic— Increased liver function tests including elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma–glutamyl transferase (GGT), alkaline phosphatase, an
