Table 4.
Adverse events, n (% of entire cohort)
| LDAA patients (n = 166) | AZAm patients (n = 118) | p-value | |
|---|---|---|---|
| Patients discontinuing treatment due to adverse events | 43 (26%) | 53 (45%) | 0.001 |
| Hepatotoxicity | 2 (1%) | 3 (3%) | 0.40 |
| Elevated LFTs without hepatotoxicity | 1 (0.6%) | 2 (2%) | 0.37 |
| Myelotoxicity | 3 (2%) | 5 (4%) | 0.22 |
| Leukopenia | 2 (1%) | 3 (3%) | – |
| Thrombocytopenia | 1 (0.6%) | 1 (0.8%) | – |
| Leukopenia and thrombocytopenia | 0 | 1 (0.8%) | – |
| Gastro-intestinal complaints | 22 (13%) | 22 (19%) | 0.22 |
| Fatigue | 8 (5%) | 6 (5%) | 0.92 |
| Dizziness | 6 (4%) | 5 (4%) | 0.79 |
| Arthralgia | 5 (3%) | 3 (3%) | 0.81 |
| Alopecia | 3 (2%) | 0 | 0.14 |
| Pancreatitis | 3 (2%) | 4 (3%) | 0.40 |
| Malaise | 2 (1%) | 4 (3%) | 0.21 |
| Headache | 2 (1%) | 6 (5%) | 0.05 |
| Rash | 0 | 4 (3%) | 0.02 |
| Serious infection | 1 (0.6%) | 1 (0.8%) | 0.81 |
| Malignancy | 0 | 0 | – |
| Unknown | 2 (1%) | 2 (2%) | – |
| Other | 5 (3%) | 11 (9%) | – |
| Patients experiencing adverse events | 80 (48%) | 68 (58%) | 0.12 |
| Hepatotoxicity | 11 (7%) | 8 (7%) | 0.96 |
| Elevated LFTs without hepatotoxicity | 13 (8%) | 10 (8%) | 0.84 |
| Myelotoxicity | 18 (11%) | 11 (9%) | 0.17 |
| Leukopenia | 9 (5%) | 7 (6%) | – |
| Thrombocytopenia | 6 (4%) | 1 (0.9%) | – |
| Leukopenia and thrombocytopenia | 3 (2%) | 3 (3%) | – |
| Gastro-intestinal complaints | 24 (15%) | 24 (20%) | 0.19 |
| Fatigue | 12 (7%) | 7 (6%) | 0.67 |
| Dizziness | 6 (4%) | 6 (5%) | 0.54 |
| Arthralgia | 5 (3%) | 4 (3%) | 0.86 |
| Alopecia | 3 (2%) | 0 | 0.14 |
| Pancreatitis | 3 (2%) | 4 (3%) | 0.40 |
| Malaise | 3 (2%) | 5 (4%) | 0.22 |
| Headache | 5 (3%) | 6 (5%) | 0.37 |
| Rash | 0 | 4 (3%) | 0.02 |
| Serious infection | 1 (0.6%)a | 1 (0.9%)b | 0.81 |
| Malignancy | 0 | 0 | – |
| Unknown | 3 (2%) | 2 (2%) | – |
| Other | 7 (4%) | 12 (10%) | – |
LDAA low-dose azathioprine with allopurinol, AZAm azathioprine monotherapy, LFTs liver function tests
aRespiratory tract infection
bCMV reactivation