Table 3.
Adverse events. The table includes the number of patients allocated to l-azathioprine (L-AZA)/ allopurinol (ALLO) versus AZA with adverse events among patients who received at least one dose of the study drug. The numbers in the parentheses indicate the time to withdrawal of treatment (weeks) for patients who had to discontinue treatments.
| L-AZA/ALLO N = 47 | AZA N = 42 | |
|---|---|---|
| Total Adverse Events (n)* | 80 | 77 |
| Serious Adverse Events | 3 (6%) | 3 (7%) |
| Total number of withdrawals | 14 (30%) | 16 (38%) |
| Causes for withdrawals | ||
| Increased Alanine aminotransferase | 3 (3‒15 weeks) | 3 (3‒7 weeks) |
| Nausea | 6 (2‒10 weeks) | 6 (3‒27 weeks) |
| Infections | 2 (2‒10 weeks) | 3 (1‒5 weeks) |
| Leukopenia | 1 (8 weeks) | 1 (5 weeks) |
| Rash | 1 (10 weeks) | 0 |
| Fatigue | 1 (25 weeks) | 0 |
| Joint/muscle pain | 0 | 2 (6‒42 weeks) |
| Headache | 0 | 1 (7 weeks) |
Some patients had more than one adverse event.