Table 3.
Adverse events reported in the MTX population in the first 12 weeks
| Adverse Event description | Frequency | Definitely or probably related to MTX | AE severity | MTX held | MTX stopped | SAE frequency | ||
|---|---|---|---|---|---|---|---|---|
| Mild | Mod | Severe | ||||||
| Fatigue | 16 | 10 | 9 | 7 | 0 | 2 | 1 | 0 |
| Hair loss/alopecia | 5 | 4 | 4 | 1 | 0 | 0 | 0 | 0 |
| Nausea | 40 | 37 | 30 | 10 | 0 | 11 | 5 | 0 |
| Vomiting | 2 | 1 | 1 | 1 | 0 | 1 | 0 | 0 |
| Diarrhoea | 4 | 3 | 2 | 2 | 0 | 1 | 0 | 0 |
| Abdominal/GI upset | 13 | 8 | 11 | 2 | 0 | 4 | 1 | 0 |
| Mouth ulcer/cold sores | 7 | 4 | 3 | 2 | 2 | 3 | 0 | 0 |
| Sore throat | 7 | 1 | 5 | 2 | 0 | 6 | 0 | 0 |
| Cough | 4 | 0 | 2 | 2 | 0 | 1 | 0 | 0 |
| Chest infection | 5 | 1 | 3 | 2 | 0 | 4 | 0 | 0 |
| LRTI | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Shortness of breath | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 0 |
| Fever | 4 | 0 | 3 | 1 | 0 | 1 | 0 | 0 |
| UTI | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Infection (other) | 7 | 0 | 4 | 3 | 0 | 2 | 0 | 0 |
| Headache/migraine | 11 | 3 | 5 | 5 | 1 | 4 | 1 | 1 |
| Mood disturbance/irritability | 4 | 1 | 4 | 0 | 0 | 1 | 0 | 0 |
| Liver abnormalities | 30 | 20 | 25 | 5 | 0 | 18 | 4 | 0 |
| Anaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 3 | 2 | 2 | 1 | 0 | 1 | 0 | 0 |
AE = adverse event, MTX = methotrexate, SAE = serious adverse event