Table 5.
Adverse events during administration of study drug
| Event, n (%) | MMF (n = 74) | Placebo (n = 77) | P |
|---|---|---|---|
| Permanent withdrawal of study drug because of toxicity | 3 (4) | 4 (5) | .99 |
| Temporary withdrawal of study drug | 23 (31) | 22 (29) | .73 |
| Any infection | 55 (74) | 67 (87) | .05 |
| Any bacterial infection | 18 (24) | 16 (21) | .60 |
| Any viral infection | 27 (36) | 27 (35) | .86 |
| Any fungal infection | 18 (24) | 24 (31) | .35 |
| Pneumonia | 17 (23) | 10 (13) | .11 |
| Conjunctivitis | 4 (5) | 11 (14) | .07 |
| Empiric antibiotic treatment | 23 (31) | 14 (18) | .06 |
| Hospitalization for treatment of infection | 20 (27) | 16 (21) | .37 |
| Neutropenia episode | 13 (18) | 12 (16) | .74 |
| Thrombocytopenia | 32 (43) | 23 (30) | .09 |
| New skin cancer | 6 (8) | 9 (12) | .46 |
| Other new malignancy | 0 (0) | 3 (4) | .25 |
| Avascular necrosis | 4 (5) | 3 (4) | .72 |
| Diabetes mellitus | 17 (23) | 15 (19) | .60 |
| Osteoporosis | 14 (19) | 13 (17) | .74 |
| Thyroid disease | 8 (11) | 16 (21) | .09 |
Includes events occurring within 30 days after administration of study drug was discontinued.