Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
transplantation. Using binomial theory, we cannot reject the hypothesis that the 
concordance rate exceed 50% at alpha =0.05, if: 
i) Five of the first five positive patients are also marker gene positive, or 
ii) Seven of the first eight agree. 
If this occurs, no further culture positive neuroblastoma patients will have an unpurged 
aliquot. 
6.3.8 ADVERSE REACTIONS 
The Adverse Reaction Form will be completed if adverse reactions occur. Severe 
reactions will be immediately reported to the designated representative of Baxter 
Healthcare Corporation Immunotherapy Division, or alternate designee and followed by 
a complete written report documenting the reaction, probable cause and outcome. 
(Provided at the end of this section is a guideline for attributing side effects to the 
treatment). 
If the Medical Department needs to be reached after normal business hours to report 
adverse reactions or to answer any questions concerning a patient’s eligibility into the 
study, etc., home phone numbers are provided. 
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