Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat

Table 4

List of unscheduled deaths and contributing causes.

(a) 26-Week Study

Sex	Time of death (week)	Found dead	Euthanasia for welfare reasons	Major factors contributing to death
0 IU/kg (control)
Female	13		X	Combination of findings contributed to overall poor clinical condition
Female	R 7		X	Urogenital lesions
Female	R 22		X	Lymphoma
150 IU/kg
Female	10		X	Alimentary tract lesions
Female	11		X	Combination of findings contributed to overall poor clinical condition
Male	26	X		Myocarditis and epicarditis
Male	26	X		No factors contributing to death identified
500 IU/kg
Female	25		X	Combination of findings contributed to overall poor clinical condition
1200 IU/kg
Male	13		X	Urogenital lesions
Male	21		X	Combination of findings contributed to overall poor clinical condition
Male	R 22		X	Septicemia (sequela of skin ulceration)

Note. R = week of 26-week recovery phase.

(b) 52-week study

Sex	Time of death (week)	Found dead	Euthanasia for welfare reasons	Major factors contributing to death
0 IU/kg (control)
Female	6		X	Combination of findings contributed to overall poor clinical condition
Male	7		X	Combination of findings contributed to overall poor clinical condition
Male	9		X	Abscess
Female	13		X	Malignant schwannoma
Male	21		X	Gastrointestinal lesions
Male	25		X	Urogenital lesions
Male	28		X	Abscess
Female	34		X	Nasal turbinate lesion
Male	40		X	Eye lesions
Male	41	X		Kidney lesions
Male	46		X	No factors contributing to death identified
Male	47		X	Urogenital lesions
Female	51		X	Sarcoma
Male	R 4		X	Abscess
50 IU/kg
Female	26		X	Malignant oligodendroglioma
Male	38		X	Lymphoma
Male	40		X	Nasal turbinate lesions
Male	41		X	Gastrointestinal lesions
Male	41	X		Lymphoma
Male	42		X	Lymphoma
150 IU/kg
Male	7		X	Abscess
Male	11		X	Combination of findings contributed to overall poor clinical condition
Male	34		X	Skin lesions
Male	43		X	Sarcoma
Male	43	X		Lymphoma
Male	45	X		Lymphoma
Male	49		X	Kidney lesions
500 IU/kg
Female	10		X	Gastrointestinal lesions
Male	12		X	Peritonitis
Male	15		X	Joint lesions
Female	17	X		No factors contributing to death identified
Female	27		X	No factors contributing to death identified
Female	29		X	Gastrointestinal lesions
Male	42	X		No factors contributing to death identified
Female	44		X	Skin lesions
Female	45	X		Atrial thrombosis
1200 IU/kg
Female	11		X	Kidney lesions
Female	11		X	Skin lesions
Female	12	X		Urogenital lesions
Female	16		X	Gastrointestinal lesions
Male	22		X	Joint lesions
Male	28	X		Abscess
Male	31		X	Skin lesions
Female	46		X	Gastrointestinal lesions
Male	R 12		X	Squamous cell sarcoma

Note. R = week of 12-week recovery phase.