Research Article
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) |
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Note. R = week of 26-week recovery phase.
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(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 |
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Note. R = week of 12-week recovery phase.
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