Table 2 –
AE terminology | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | |
---|---|---|---|---|---|---|---|
1 | Abdominal pain | 1 | 1 | 2 | |||
2 | Alkaline phosphatase increased | 2 | 2 | ||||
3 | ALT increased | 1 | 1 | ||||
4 | AST increased | 1 | 1 | ||||
5 | Epigastric pain | 1 | 1 | ||||
6 | Fatigue | 1 | 1 | 2 | |||
7 | Lymphocyte count decreased | 1 | 1 | ||||
8 | Nausea | 2 | 1 | 3 | |||
9 | Small intestinal perforation | 1 | 1 | ||||
10 | Vomiting | 1 | 1 | ||||
Total: grade 1 | 11 | ||||||
Total: grade 2 | 3 | ||||||
Total: grade 3 | 1 | ||||||
Total: grade:4 | 0 | ||||||
Total: grade:5 | 0 | ||||||
Sum of grades | 15 |
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate transaminase.