8.4.1 No serious adverse event (Section 9.1.2) has occurred. 
8.4.2 Any dose-limiting toxicity (Section 8.2.1) has fully resolved. 
8.4.3 It is the clinical judgment of the principal investigator and the attending surgeon that 
the study padent is surgically fit and at no greater risk for an adverse event than any 
other (non-study) patient by undergoing the laparotomy. 
8.5 T oxicity Management 
All toxic events will be managed with full and optimal supportive care, including transfer to 
the intensive care unit (ICU) if appropriate. See also Section 13.0, Concomitant or 
Ancillary Therapy. 
9.0 ADVERSE DRUG REACTION (ADR) REPORTS 
9.1 Definitions 
9.1.1 The terms "adverse event", "adverse experience", and "adverse reaction" 
include any adverse event whether or not considered drug-related. This 
includes any side effect, injury, toxicity, or sensitivity reaction. 
9.1.2 An adverse event is considered serious if any of the following occur: 
1) it is fatal or life-threatening; 
2) it is severely or permanently disabling; 
3) it requires new or prolonged inpatient hospitalization; 
4) it involves development of a congenital anomaly or cancer; or 
5) it results from an overdose. 
9.1.3 An adverse event is considered unexpected if it is not identified in nature, 
severity, or frequency in the current investigator brochure. 
9.2 Adverse Event Reporting Requirements 
9.2.1 Patients will be instructed to report any adverse event to the investigators 
(Principal Investigator or Co-Investigator). 
9.2.2 All adverse events occurring during participation in the study must be 
reported on the appropriate case report form (CRF). 
9.2.3 The report will include a description of the severity, duration, and outcome 
of the event, and the investigator's opinion regarding the relationship, if 
any, between the event and the study treatment. 
9.2.4 The Medical Monitor representing Canji, Inc. for this study will be 
immediately notified (within 24 hours) of any Grade 3 or 4 toxicity. 
Medical Monitor 
Telephone: 
Pager: 
John W. Park, M.D. 
(415)476-1421 
(415)719-1105 
Alternate Contact: Clinical Research 
Recombinant DNA Research, Volume 20 
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