Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
6.3.8. 1 Definition of Terms: Clinical Adverse Experiences 
CATEGORIES FOR DETERMINING RELATIONSHIPS TO STUDY MATERIAL 
NONE: The adverse reaction is known definitively to be due to another cause and is 
therefore unrelated to the study material. 
REMOTE: In general, this category can be considered applicable to those adverse 
experiences that, after careful medical consideration at the time they are 
evaluated, are judged to be unrelated to the in vitro manipulation of the 
marrow (marking/purging). An adverse experience may be considered 
remote if or when, for example: 
1. It does not follow a reasonable temporal sequence from reinfusion 
of marked/purged marrow. 
2. It was most likely produced by the patient’s clinical condition, 
environmental or toxic factors, or other modes of therapy 
administered to the patient. 
3. It does not follow a known response pattern to. the use of 
immunomagnetic purging. 
POSSIBLE: This category applies to those adverse experiences for which, after careful 
consideration at the time they are evaluated, the connection with the in 
vitro marrow manipulation appears unlikely but cannot be ruled out with 
certainty. An adverse experience may be considered possible if or when: 
1. It follows a reasonable temporal sequence from reinfusion of 
marked/purged marrow. 
Recombinant DNA Research, Volume 16 
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