9.4 Potential side effects and reporting of adverse 
reactions. 
Adverse Drug Reactions will be reported to the Drug 
Information Service, University of Michigan Medical Center, phone 
313-936-8200 or 313-936-8251 (available 24 hours) , and include 
all life-threatening events (Grade 4) which may be due to drug 
administration, all fatal events, or the first occurrence of any 
previously unknown clinical event (regardless of Grade) . A 
written report is to follow within 10 working days to: 
Investigational Drug Branch 
P.0. Box 30012 
Bethesda, Maryland 20824 
Phone: 301-496-7957 
Data will be submitted to the IRB monthly or upon request. All 
adverse reactions will be reported to the IRB, even if there is 
only a suspicion of a drug effect. All side effects will be 
graded using the standard toxicity sheet described in Section 14, 
Common Toxicity Criteria. 
9.4.1 Potential risks of gene transfer in vivo. 
Insertional mutagenesis . The possibility of causing malignancy 
in cells secondary to the random insertion of the DNA in the 
genome exists, though this risk is considered low. There is a 
remote chance that the vector could replicate in the host. 
Neither finding has been seen in animal studies (-200 mice, 
rabbits, and pigs) ; nonetheless, the proposed protocol provides 
for extensive testing of tumor tissue and blood after injection 
Recombinant DNA Research, Volume 15 
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