Incidence of AEs that emerged during treatment and serious AEs
| Event | EC-MPS (n=120) | AZA (n=120) | p Value |
| No of patients (%) | |||
| All AEs* | 71 (59.2) | 69 (57.5) | 0.793 |
| All serious AEs | 11 (9.2) | 13 (10.8) | 0.667 |
| All AEs leading to withdrawal | 4 (3.3) | 10 (8.3) | 0.098 |
| Frequent non-serious AEs | |||
| Upper gastrointestinal symptoms | 9 (7.5) | 16 (13.3) | 0.139 |
| Liver toxicity | 0 | 3 (2.5) | 0.081 |
| Infectious | 34 (28.3) | 26 (21.6) | 0.233 |
| Upper respiratory tract infection | 16 (13.3) | 12 (10) | 0.421 |
| Pneumonia | 3 (2.5) | 1 (0.8) | 0.313 |
| Urinary tract infection | 4 (3.3) | 4 (3.3) | 1.00 |
| Herpes varicella zoster | 5 (4.2) | 3 (2.5) | 0.472 |
| Skin and soft tissue infection | 2 (1.7) | 2 (1.7) | 1.00 |
| Influenza | 3 (2.5) | 2 (1.7) | 0.651 |
| Oral candidiasis | 1 (0.8) | 2 (1.7) | 0.313 |
| Leucopenia | 0 | 5 (4.2) | 0.024 |
| Serious AEs | |||
| Death | 1 (0.8) | 1 (0.8) | 1.00 |
| Malignant conditions | 1 (0.8) | 3 (2.5) | 0.313 |
| Pneumonia | 4 (3.3) | 3 (0.8) | 0.701 |
| Pyelonephritis | 1 (0.8) | 2 (1.7) | 0.313 |
| Soft tissue infection | 0 | 2 (1.7) | 0.157 |
| Acute coronary syndrome | 0 | 1 (0.8) | 0.316 |
| CVA | 3 (2.5) | 1 (0.8) | 0.313 |
| Subarachnoid haemorrhage | 1 (0.8) | 1 (0.8) | 1.00 |
The terms used to describe the events are those preferred by the Medical Dictionary for Regulatory Activities, version 12.0. Only AEs that occurred during treatment are listed; these include any serious and non-serious AE that occurred between the date of the first dose and the date of last visit plus 30 days. Multiple occurrences of the same AE in one person were counted only once. SLE flares were not considered AEs.
This category includes all patients who had at least one AE.
AE, adverse event; AZA, azathioprine; CVA, cerebrovascular accident; EC-MPS, enteric-coated mycophenolate sodium; SLE, systemic lupus erythematosus.