Table 4 Toxicity in the three treatment arms
Treatment arm | Arm 1 Sequential monotherapy MTX or SSZ n = 32 | Arm 2 Combo MTX + 6 wks prednisone n = 32 | Arm 3 Combo MTX + etanercept n = 30 |
|---|---|---|---|
Total number of AEs | 33 | 46 | 39 |
Number of SAEs | 2 | 1 | 0 |
Cardiovascular | 0 | 0 | 1 |
Pulmonary | 1 | 2 | 0 |
Gastrointestinal | 7 | 14 | 9 |
 -Nausea | 3 | 8 | 6 |
 -Vomiting | 0 | 3 | 1 |
 -Diarrhoea | 0 | 1 | 1 |
 -Rectal Blood loss | 1 | 0 | 0 |
 -Liver enzyme abnormality | 3 | 2 | 2 |
Neurologic | 4 | 3 | 2 |
 -Headache | 2 | 0 | 1 |
 -Sleeping disturbances | 1 | 2 | 0 |
 -Behavioral problems | 1 | 1 | 1 |
Leukopenia | 5 | 1 | 1 |
Skin/mucosal membranes | 3 | 4 | 3 |
Infectious | 8 | 6 | 13 |
 -Upper respiratory tract infection | 1 | 1 | 8 |
 -Gastro-enteritis | 0 | 1 | 1 |
 -Skin/mucosal infection | 1 | 1 | 2 |
 -Fever | 2 | 1 | 1 |
 -Infectious other | 1 | 2 | 1 |
General malaise/fatigue | 3 | 5 | 1 |
Other | 0 | 3 | 2 |