Table 2.
Level 1 | Level 2 | Level 3 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Patient no. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
Appetite loss | 2 | 2 | |||||||||
General fatigue | 2 | ||||||||||
Nausea | 2 | 2 | |||||||||
Vomiting | 2 | 2 | |||||||||
Ileus | 2 | 3 | |||||||||
Constipation | 2 | 2 | 2 | ||||||||
Diarrhea | 2 | ||||||||||
Abdominal pain | 2 | 2 | |||||||||
Abdominal fullness | 2 | 3 | |||||||||
Intraabdominal bleeding | 2 | ||||||||||
Lumbago | 2 | ||||||||||
Headache | 2 | ||||||||||
Fever | 2c | 2c | |||||||||
Dyspnea | 2 | ||||||||||
Hematomaa | 2 | ||||||||||
Erythema | 2 | ||||||||||
Anemia | 2 | 2 | 2 | 3 | 2 | ||||||
Elevation of ALT | 2 | ||||||||||
Elevation of CRP | 2 | 2c | 2c | ||||||||
Hypoalbuminemia | 2 | 2 | |||||||||
Hypotensionb | 3c | 3c |
aHematoma in the inserted port
bTransient hypotension accompanied by abdominal peritoneal irritation
cAdverse events during the administration of BK-UM
No asterisk in adverse events indicates events monitored during the observation period after the administration of BK-UM