The case report form will completely describe the departure and 
state the reasons for it. 
9.5 Adverse Experiences 
The investigator is required to immediately notify the sponsor 
in writing of any unexpected, fatal or life-threatening 
experiences and all unusual, alarming or serious drug reactions 
or surgical complications, regardless of any opinions as to the 
cause/effect relationship. The sponsor is required to notify the 
FDA by telephone of unexpected fatal or life-threatening events 
associated with the use of the study treatment no later than three 
working days after receipt of the information. In addition, all 
serious, unexpected adverse events that are associated with the 
use of the study treatment must be filed with the FDA by the 
sponsor within ten working days of the initial notification. 
All deaths, whether considered study /therapy related or not, 
must be reported immediately to the sponsor, with a copy of the 
autopsy report (if done) and the death certificate. (This includes 
deaths occurring within 4 weeks of stopping treatment and 
deaths occurring during the protocol defined follow-up period.) 
Any serious, unexpected adverse experience (including all 
deaths) must be reported to the Institutional Review Board 
within ten days and documentation of this report must be sent 
to the sponsor. A serious adverse event is defined as: fatal or 
life threatening, permanently disabling, requires inpatient 
hospitalization or prolongation of hospitalization, is a 
congenital anomaly, cancer or overdose. 
All adverse experiences must be recorded on the Adverse 
Experience Case Report Form. The report should include: 
severity, duration, outcome and the investigator's written 
medical judgment as to relationship of the adverse experience to 
the study procedure (i.e. "unrelated", "probably", "possibly" or 
"unknown"). 
10.0 WITHDRAWAL FROM THE STUDY 
Patients may be removed from the study for the following reasons: 
a) An intercurrent illness which would, in the judgment of 
the Principal Investigator, affect the assessment of the 
patient's clinical status to a significant degree, require the 
discontinuation of therapy, or both. 
b) Unacceptable toxicity as listed in section 9.3 using the NCI 
toxicity guidelines. 
c) Patient non-compliance with the study protocol. 
d) Patient voluntarily decides to withdraw. 
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