8.0 
ADVERSE EVENTS AND REMOVAL FROM STUDY 
8.1 Patients will be monitored and questioned at every visit (see Schedule of Events) 
regarding the occurrence and nature of any adverse experiences. An event is 
any change in the physiological or psychological state other than the primary 
condition that qualifies the patient for tius study. 
8.2 The Investigator must report to Mr. Steven Kradjian (ph 619-453-9900, available 
24 hours.) upon occurrence of any life-threatening events (Grade IV) that may be 
attributable to administration of the study drug, all fatal events, or the first 
occurrence of any previously unknown clinical event (regardless of Grade). A 
written report is to follow within 3 working days to: 
Steven A. Kradjian 
Vical Inc. 
9373 Towne Centre Drive, Suite 100 
San Diego, CA 92121 
8.3 Patients \W11 be taken off study immediately if : 
8.3.1 Unacceptable toxicity (Grade HI or IV) develops and is not easily corrected (refer 
to WHO toxicity sheet). 
8.3.2 Development of Progressive Disease (see definition 9.2.4) requiring the 
institution of alternative treatments such as radiation, surgery or other drug 
therapy. 
8.3.3 If the Investigator believes that the patient's best interest requires a change of 
therapy. 
8.3.4 At the patient's or gucirdian's request. 
9.0 EFFICACY CRITERIA 
9.1 Pharmacologic/Immunologic Studies 
As part of the measurement of the efficacy in this study, successful gene transfer and 
expression will be evaluated by molecular genetic and immunological analyses. 
Several independent techniques will be used to evaluate the presence and expression of 
the recombinant gene in vivo. 
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