MEDICAL RECORD 
STUDY NUMBER: 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Studv 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
CONTINUATION: page of M_ pages. 
Total Body Irradiation may cause nausea and vomiting, hair 
loss, inflammation of the parotid gland and pancreas, 
diarrhea, fever, infection, pneumonia, skin rash or dark 
pigmentation, and mouth sores. Years after total body 
irradiation you may have a higher chance of getting a second 
type of cancer, and of developing cataracts (clouding of the 
eyes ) . 
Bone Harrow and Peripheral Blood Infusion may cause allergic 
reactions which appear as chills, fever and hives, volume 
overload, blood clotting, shortness of breath, (rarely) 
kidney failure, and low blood pressure. 
Transplant procedure fin general) will lead to an extremely 
high susceptibility to infections. It is possible that your 
bone marrow will not recover at all after your high dose 
therapy and reinfusion. Though this happens in less than 5% 
of patients, failure of your bone marrow to recover would 
most likely result in death due to infections and bleeding. 
Because you will be receiving both bone marrow and 
peripheral blood stem cells this risk will be reduced but 
not completely eliminated. 
Once your bone marrow has engrafted (recovered in your 
body), you have adequate blood values, and you are free from 
infection you will be discharged from the hospital. We 
expect this will take 4-6 weeks. You will be followed 
closely in the out-patient clinic up until at least 60 days 
post-transplant. We will continue to draw blood twice 
weekly to check your blood counts and some body function 
tests (such as liver function). After day +60 you will 
begin monthly evaluations at NIH to be continued for the 
first year post-transplant. These visits will include blood 
tests and a general assessment of your condition. A bone 
marrow biopsy and aspirate (approximately 30 ml or about 2 
Tablespoons of marrow withdrawn) will be done every three 
months. Peripheral blood (50 ml. or 3-4 Tablespoons) will 
also be collected every three months. This will allow us to 
closely monitor your health status and determine if your 
bone marrow continues to recover. After the first year you 
will be followed at NIH at least once a year for five years. 
patient identification 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[189] 
c **0 >1 t *320 
