evaluate response to treatment. Serum will be analyzed by PCR 
for the presence of plasmid, and antibody to Rev M10 will be 
evaluated. PBL's will be isolated and analyzed for their ability 
to lyse Rev M10 modified autologous EBV-transformed lines. If 
ANA becomes positive or other signs of autoimmunity appear, 
evidence of more specific autoantibodies, e.g., anti-Rho, Smith, 
etc. , will be tested and rheumatology consultation will be 
sought. 
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. 
[24] 
Recombinant DNA Research, Volume 18 
