Table 2 Adverse events
Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
|---|---|---|---|---|
Adverse Reactions at least possibly related to glucarpidase (All) | ||||
Abdominal pain | – | 1 (2) | – | – |
Dyspnea | – | 1 (2) | – | – |
Fecal incontinence | 1 (2) | – | – | – |
Flushed face | 1 (2) | – | – | – |
Headache | – | 1 (2) | – | – |
Nausea | 3 (5) | – | – | – |
Adverse Reactions at least possibly related to methotrexate (All grade 3 and higher, most common > 10% grade 1–2) | ||||
Alanine aminotransferase increased | 12 (22) | 2 (4) | 1 (2) | – |
Anemia | 10 (18) | 12 (22) | 5 (9) | – |
Aspartate aminotransferase increased | 17 (31) | 2 (4) | 1 (2) | – |
Blood billirubin increased | 11 (20) | 3 (5) | – | – |
Creatinine increased | 2 (4) | 3 (5) | – | – |
Hypoalbuminemia | 10 (18) | 2 (4) | – | – |
Hypokalemia | 7 (13) | 1 (2) | 2 (4) | – |
Lung infection | – | – | 1 (2) | – |
Lymphocyte count decreased | 7 (13) | 15 (27) | 10 (18) | – |
Nausea | 8 (15) | 4 (7) | – | – |
White blood cell count decreased | 8 (15) | 3 (5) | 1 (2) | – |