MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 
CONTINUATION: pagejL_ofii 
— pages. 
to destroy as many leukemic cells in your bone marrow and 
blood as possible, and to increase the percentage of nan- 
leukemic cells in your bone marrow and blood before 
collecting cells to be used for transplantation. 
Daunorubicin often causes low blood counts, nausea, 
vomiting, inflammation of the mouth, inflammation of the 
throat, loss of appetite, temporary hair loss and diarrhea. 
More rarely it can cause kidney damage, red-colored urine, 
liver damage, skin rash, fever, chills heart damage, and 
changes in heart rate. 
Cvtarabine often causes low blood counts, nausea, vomiting, 
diarrhea, mouth and throat inflammation, skin rash and more 
rarely causes mild and reversible (damage will end when drug 
, is stopped) liver damage; inflammation of the cornea in the 
eyes, and nervous system irritation and damage. 
You will need to be an inpatient in the Clinical Center at NIH 
for 3-5 weeks after the chemotherapy treatment. This is because 
your blood counts will be low and you will need antibiotics, 
transfusions and other supportive care until your bone marrow, 
recovers. There is a small chance that you could die from a „ 
serious infection or bleeding as a result of this chemotherapy 
treatment. 
3) G-CSF (granulocyte colony-stimulating factor): Daily G-CSF 
intravenous infusions will be given beginning the day after 
you complete the above chemotherapy. This human protein is 
produced for medical use in bacteria or yeast. It 
stimulates the bone marrow to release “stem cells' 1 (the 
cells from which all the different types of cells in bone 
marrow and blood develop), into the circulating blood (where 
they can be harvested by apheresis). G-CSF treatment may 
also speed the recovery of your blood counts from the 
daunorubicin and cytarabine chemotherapy. The G-CSF 
treatment will continue until your peripheral blood stem 
cell collection is completed and your white blood cell count 
has recovered from the chemotherapy. 
GM-CSF may cause headaches, fatigue, confusion, allergic 
reactions, fluid retention, anorexia, nausea, vomiting, 
abnormal taste, flu-like symptoms (fever, chills), bone 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
[184] 
Recombinant DNA Research, Volume 16 
CPO •» f *329 
