Association between Rash and a Positive Drug Response Associated with Vinorelbine in a Patient with Primary Peritoneal Carcinoma

Table 2

Summary of nonhematological adverse events in 365 patients receiving single agent VRL∗†.

Adverse event	All grades		Grade 3		Grade 4
	All patients	NSCLC	All patients	NSCLC	All patients	NSCLC
Clinical chemistry elevations
Total bilirubin (𝑛 = 351)	13%	9%	4%	3%	3%	2%
SGOT (𝑛 = 346)	67%	54%	5%	2%	1%	1%
General
Asthenia	36%	27%	7%	5%	0%	0%
Injection site reactions	28%	38%	2%	5%	0%	0%
Injection site pain	16%	13%	2%	1%	0%	0%
Phlebitis	7%	10%	<1%	1%	0%	0%
Digestive
Nausea	44%	34%	2%	1%	0%	0%
Vomiting	20%	15%	2%	1%	0%	0%
Constipation	35%	29%	3%	2%	0%	0%
Diarrhea	17%	13%	1%	1%	0%	0%
Peripheral neuropathy^‡	25%	20%	1%	1%	<1%	0%
Dyspnea	7%	3%	2%	2%	1%	0%
Alopecia	12%	12%	≤1%	1%	0%	0%

∗None of the reported toxicities were influenced by age. Grade based on modified criteria from the National Cancer Institute.
^†Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy.
^‡Incidence of paresthesia plus hypesthesia (http://www.fda.gov/ohrms/dockets/ac/04/briefing/4021b1_10_vinorelbine%20label.pdf).