Table 4.
Grade 2 adverse drug reactions and Grade 3–4 adverse events reported in ≥10% of patients overall.
| Event term | Grade 2 adverse drug reactions* | Grade 3–4 adverse events | Total |
|---|---|---|---|
| Abdominal pain | 3 | 6 | 9 |
| Alanine aminotransferase increased | 5 | 4 | 9 |
| Anaemia | 24 | 6 | 30 |
| Fatigue | 22 | 5 | 27 |
| Mucositis oral | 7 | 0 | 7 |
| Nausea | 15 | 4 | 19 |
| Neutrophil count decreased | 19 | 23 | 42 |
| Platelet count decreased | 4 | 4 | 8 |
| Vomiting | 7 | 5 | 12 |
| White blood cell decreased | 13 | 8 | 21 |
| Total | 119 | 65 | 184 |
*An adverse drug reaction is an AE that is considered to be causally related to any dose of the 6MP or methotrexate.