Table 2.

Adverse Events After AdV-tk Injection During Valacyclovir and the First 2 Weeks of Radiation (weeks 1-3) and After Valacyclovir Through Completion of Radiation (weeks 4-8)

Adverse Events	Weeks 1-3				Weeks 4-8
	CTC Grade				CTC Grade
	1	2	3	4	1	2	3	4
Cardiac
Ischemia							1
Constitutional
Fatigue	1				2	1
Fever		1*
Insomnia					1
Dermatologic
Rash	1
Wound complication							1*
GI
Anorexia/weight loss	1
Constipation	3				2	1
Nausea/vomiting	1	1*			2
Hematologic
Hemoglobin	3	2	1			1
Leukopenia					1
Platelets	1				2
Hemorrhage
Epistaxis	1
Hematoma, while on heparin							1
Infection
Sinus	1
Laboratory
ALT	7*	2*	1*			1*
AST	4*	1*			1*
Bilirubin						1
Creatinine	1	1*			2
Hyponatremia	5		1*
Lymphatics
Edema, lower extremities	1				1
Neurologic
Ataxia	1
Confusion		1*
CSF leak		1
Dizziness					1
Hydrocephalus		1*
Mood alteration, anxiety		1
Mood alteration, depression	1*	1			2
Neuropathy, cranial	2	1
Neuropathy, motor		1*
Seizure		1
Speech impairment		1*				1
Pain
Headache	1*	1*
Chest, not cardiac	3
Postoperative		1
Pulmonary
Dyspnea (COPD flare-up)		1
Renal/genitourinary
Urinary retention with UTI		1
Vascular
Deep venous thrombosis			1				1

NOTE. Most events were deemed unrelated to the adenoviral vector containing the herpes simplex virus thymidine kinase gene (AdV-tk) + prodrug except those marked with an asterisk which were deemed possibly related. These events were transient.

Abbreviations: COPD, chronic obstructive pulmonary disease; CSF, cerebrospinal fluid; CTC, Common Terminology Criteria for Adverse Events version 3.0; UTI, urinary tract infection.