Table 4.
Serious Adverse Events (SAEs) during the three-year post-trial phase.
| Randomization population1 | On-treatment population2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MMF group3(N = 48) | Control group4(N = 22) | Group I5(N = 56) | Group II6(N = 14) | Total(N = 70) | ||||||
| nE | nP | nE | nP | nE | nP | nE | nP | nE | nP | |
| Total SAEs | 36 | 11 | 36 | 11 | 47 | |||||
|
| ||||||||||
| Total patients with at least one SAE | 21 (43.8%) |
8 (36.4%) |
23 (41.1%) |
6 (42.9%) |
29 (41.4%) |
|||||
|
| ||||||||||
| P-value | .560 | .903 | ||||||||
|
| ||||||||||
| Infections* | 8 | 6 (12.5%) |
2 | 2 (9.1%) |
8 | 6 (10.7%) |
2 | 2 (14.3%) |
10 | 8 (11.4%) |
| Cardiac disorders* | 4 | 4 (8.3%) |
1 | 1 (4.6%) |
3 | 3 (5.4%) |
2 | 2 (14.3%) |
5 | 5 (7.1%) |
| Tumors* (benign, malignant, not specified) | 3 | 3 (6.3%) |
2 | 2 (9.1%) | 4 | 4 (7.1%) |
1 | 1 (7.1%) |
5 | 5 (7.1%) |
| Surgical and medical interventions* | 4 | 4 (8.3%) |
— | — | 3 | 3 (5.4%) |
1 | 1 (7.1%) | 4 | 4 (5.7%) |
| Gastrointestinal disorders* | 2 | 2 (4.2%) |
1 | 1 (4.6%) |
2 | 2 (3.6%) |
1 | 1 (7.1%) |
3 | 3 (4.3%) |
| Urinary system and kidney disorders* | 2 | 2 (4.2%) |
1 | 1 (4.6%) |
3 | 3 (5.4%) |
— | — | 3 | 3 (4.3%) |
| Respiratory, thoracic, and mediastinal disorders* | 3 | 3 (6.3%) |
— | — | 2 | 2 (3.6%) |
1 | 1 (7.1%) |
3 | 3 (4.3%) |
1Patients randomized to receive either MMF or CsA treatment in the initial study phase.
2Determined by the treatment patients received at the end of the post-trial phase (mycophenolic acid derivative or not).
3Patients who received 2 g MMF per day and 50% of the initial CsA dose.
4Patients who received the usual CsA dose.
5Patients who received a treatment with a mycophenolic acid derivative at the end of the follow up phase.
6Patients without a mycophenolic acid derivative at the end of the follow up phase.
Note: percentages were calculated based on the number of patients per group, nE: number of events, nP: number of patients. * details of SAEs per system/organ were done for ones with an incidence ≥3%.