Table 3.
Adverse events
| Adverse Events | Total, n=84 | MMF, n=41 | Cyclophosphamide, n=43 |
|---|---|---|---|
| AEs, n (%) | 102 | 47 | 55 |
| AE grade 1 or 2 | 75 (74%) | 34 (72%) | 41 (75%) |
| AE grade 3 | 19 (19%) | 8 (17%) | 11 (20%) |
| AE grade 4 | 2 (2%) | 2 (4%) | 0 (0%) |
| AE grade 5 | 6 (6%) | 3 (6%) | 3 (5%) |
| Infections, n (%) | 46 | 19 | 27 |
| Episodes of infections on induction treatment | 19 (41%) | 8 (42%) | 11 (41%) |
| ≥1 infection during induction, participants | 13 | 7/34 (21%) | 6/40 (15%) |
| Grade ≥3 | 5 (11%) | 1 (5%) | 4 (15%) |
| Treatment-related AE, n participants (%) | |||
| Chemical cystitis | 1 (1%) | 0 | 1 (2%) |
| Gonadal failure | 1 (1%) | 0 | 1 (2%) |
| Diabetes mellitus | 9 (11%) | 1 (2%) | 8 (19%) |
| Malignancies | 6 | 3 | 3 |
| Intolerance MMF, n (%) | 3 (4%) | 3 (7%) | N.A. |
| Intolerance AZA, n (%) | 4 (5%) | 3 (7%) | 1 (2%) |
| Intolerance cyclophosphamide, n (%) | 0 | N.A. | 0 |
| Leukopenia, n (%) | |||
| Episodes of leukopenia on induction treatment | 15 | 3 | 12 |
| ≥1 episode of leukopenia during induction, participants | 11 | 3/35 (9%) | 8/40 (20%) |
| Episodes of leukopenia on maintenance treatment | 33 | 15 | 18 |
| ≥1 episode of leukopenia during maintenance, participants | 19 (23%) | 7 (17%) | 12 (28%) |
| Anemia, maximum AE grade, n participants (%) | |||
| Grade 1 or 2 | 73 (87%) | 35 (85%) | 38 (88%) |
| Grade 3 | 2 (2%) | 1 (2%) | 1 (2%) |
| Trombocytopenia, n participants (%) | |||
| Grade 1 | 8 (10%) | 3 (7%) | 5 (12%) |
| Grade 4a | 1 (1%) | 0 | 1 (2%) |
MMF, mycophenolate mofetil; AE, adverse event; N.A., not applicable; AZA, azathioprine.
a
As part of a severe pancytopenia.