Adverse events reported in the MTX population in the first 12 weeks. Values are n.
| Adverse Events | Frequency | Definitely or Probably Related to MTX | Adverse Events Severity | MTX Held | MTX Stopped | SAE Frequency | ||
|---|---|---|---|---|---|---|---|---|
| Mild | Moderate | 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 |
| Diarrhea | 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 |
| Anemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 3 | 2 | 2 | 1 | 0 | 1 | 0 | 0 |
MTX: methotrexate; SAE: serious adverse event; GI: gastrointestinal; LRTI: lower respiratory tract infection; UTI: urinary tract infection.