All adverse events that do not meet at least one of the above criteria are defined as non- 
serious. 
Assessment of the cause of the event has no bearing on the assessment of the event's 
severity. 
10.2 Unexpected Adverse Events 
Unexpected adverse events are those which: 
1. Are not previously reported with the tgAAVCF vector as referenced in the 
investigator brochure. 
2. Are symptomatically and pathophysiologically related to a known toxicity but 
differ because of greater severity or specificity. 
10.3 Procedure for Reporting Adverse Events 
Regulations defining the responsibilities for reporting serious and unexpected adverse 
reactions are defined in 21 CFR 312.32. To ensure that Targeted Genetics Corporation is 
in compliance with the guidelines, the reporting responsibilities of the investigators are 
summarized below: 
Serious and unexpected adverse events noted by the Principal Investigators must be 
reported immediately by telephone to the attention of: 
Tom Reynolds, M.D., Ph.D. 
(206) 521-7812 After hours (206) 623-76 1 2 
or 
Tamie Malaska, M.S. 
(206) 521-7822 After hours (206) 623-7612 
The Principal Investigators must also notify the Joint Committee on Clinical Investigation 
(JCCI) at (410)955-3008. It is also the responsibility of the investigators to notify the 
Recombinant DNA Advisory Committee of all serious and unexpected adverse events. 
The immediate telephone report must be followed by a detailed written report within 3 
working days. The report must include the date and time of onset, severity and duration of 
the event, the relationship to the study drug, the treatment given, and the eventual outcome. 
Appropriate clinical, diagnostic, and laboratory measures to attempt to delineate the cause 
of the adverse reaction in question must be performed and the results reported. All tests that 
reveal an abnormality considered to be drug-related will be repeated at appropriate intervals 
until the course is determined or a return to normal values occurs. 
All adverse events will be recorded on case report forms provided by the Sponsor. 
Information will be recorded as noted above. 
Recombinant DNA Research, Volume 20 
[131] 
