5.1.8 Hematology : Complete blood count (CBC), differential, platelets, and 
coagulation tests should include PT (Prothrombin Time), PTT (Partial 
Thromboplastin Time), and fibrinogen (Screening). 
5.1.9 Pregnancy Test : Serum pregnancy test must be negative within 7 days 
prior to Day 0, or between study days -7 and 0. 
5.2 Interval Evaluations 
Evaluations are done on a monthly basis. 
5.2.1 Objective signs and symptoms : Vital signs (blood pressure, pulse, 
temperature and respirations) weight and height will be done. 
5.2.2 Physical Examination : Target physical exam will be done on Study Days. 
5.2.3 Kamofskv Performance Status (see Appendix IV) will be done Study 
Days. 
5.2.4 Serum Chemistries : include uric acid, calcium, phosphorus, magnesium, 
amylase, triglycerides, transaminases (SGOT, SGPT), alkaline 
phosphatase, LDH, total bilirubin, BUN, creatinine, albumin, total 
protein, electrolytes, and glucose. 
5.2.5 Hematology : Complete blood count (CBC), differential, platelets, and 
coagulation tests should include PT (Prothrombin Time), PTT (Partial 
Thromboplastin Time), and fibrinogen. 
5.2.6 Pregnancy Test : Serum pregnancy test will be repeated monthly. 
5.3 Post-Treatment Evaluations 
5.3.1 The same evaluations as section 5.2 (except 5.2.5 and 5.2.6) will be 
performed bimonthly. 
5.3.2 Autopsy Request : All participants in the study will be informed that an 
autopsy will be requested to determine the extent of gene transfer into 
important organs such as marrow, liver, and spleen. 
6.0 TREATMENT MODIFICATION AND DISCONTINUATION 
ACCORDING TO LEVEL OF TOXICITY 
The GTI Table for Grading Severity of Adverse Experience (Appendix II) will be used 
to achieve consistency in response to drug/treatment toxicities. Toxicides will be graded 
on a 1 - 4 grading scale. If a toxicity is experienced, the treatment level or dose will be 
modified (if applicable) as outlined below according the grade of toxicity observed 
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Recombinant DNA Research, Volume 18 
