11.3.3 
Infusion Data (During TIL infusion on day one of week-1 
Total number of TIL infused 
Vital signs (every 15 minutes during infusion of TIL and 30 
minutes after infusion) 
11.4 Treatment Day Evaluation 
The following examinations will be performed on day one of each treatment week (weeks 
2-4, 7-10, 13-16, 19-22): 
Vital signs 
Weight 
CBC with differential, platelet count 
Urinalysis 
Serum chemistry 
Coagulation profile (PT, PTT) 
11.5 Follow-up Evaluation During Treatment 
The following examinations will be performed and recorded during weeks 6,12, 18 and 
24. 
Physical exam 
Concomitant medications 
Vital signs 
CBC with differential, platelet count 
Serum chemistry 
Urinalysis 
Coagulation profile (PT, PTT) 
Tumor assessment 
Cytokine assays only on weeks 6 and 24 (serum IL-2 and alpha interferon) 
Antibody assays only on weeks 6 and 24 (anti-rIL-2 and anti-rHuIFN-alpha 2a) 
Cytotoxicity of peripheral blood cells only on weeks 6 and 24 (K562, Daudi, 
LDCC) 
11.6 Post Treatment Follow-up 
If CAT scans are not required for tumor assessment, the following list of evaluations will 
be performed and recorded during weeks 28, 32, 36, 40, 44, and 48. if CAT scans are 
required for tumor assessment, the evaluations will be performed only durikng weeks 28 
and 40: 
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