Time to and duration of the objective response will be summarized for evaluable study 
subjects whose best response is at least a partial response. Time to objective response is 
the number of days from the start of therapy to the first documentation of objective 
response. The duration of the response is the number of days from the initial 
documentation of the objective response to the most current evaluation of that response 
or to documentation of progression. 
17. ETHICAL AND REGULATORY CONSIDERATIONS 
17.1 Informed Consent 
The principles of informed consent are described in FDA Regulations (Federal 
Register - July 27, 1981). These principles must be followed to comply with Food 
and Drug Administration Regulations. A subject must give his/her written 
consent to participate in the study. This consent must be witnessed, dated, and 
retained by the investigator as part of the study records. A copy of the consent 
form must be given to the subject. 
A copy of the Experimental Subject’s Bill of Rights must be given to the subject. 
17.2 Adverse Experiences 
All adverse experiences encountered during the clinical study will be reported. 
An adverse experience is any adverse change from the study subject’s baseline 
(pre-treatment) condition, including any clinical or laboratory test abnormality 
which occurs during the course of a clinical study after treatment has started, 
whether considered related to treatment or not. "Treatment" includes all 
investigational agents administered during the course of the study. 
Relationship of the adverse experience (unrelated, remote, possibly related, or 
probably related) to the treatment should be assessed. See Appendix IV. 
17.2.1 Reportable Adverse Experiences 
Any clinical adverse experience or abnormal laboratory test value 
that is serious or unexpected (including death, overdose, or 
congenital anomaly) occurring during the course of the study, 
irrespective of the treatment received by the patient, must be 
reported to the FDA within five working days of occurrence. The 
Institutional Review Board will be notified of such an event, in 
writing within 10 days. 
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