Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up

Table 4

Serious Adverse Events (SAEs) during the three-year post-trial phase.

	Randomization population${}^1$				On-treatment population${}^2$
	MMF group${}^3$$(N=48)$		Control group${}^4$$(N=22)$		Group I${}^5$$(N=56)$		Group II${}^6$$(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%)

${}^1$ Patients randomized to receive either MMF or CsA treatment in the initial study phase.
${}^2$ Determined by the treatment patients received at the end of the post-trial phase (mycophenolic acid derivative or not).
${}^3$ Patients who received 2 g MMF per day and 50% of the initial CsA dose.
${}^4$ Patients who received the usual CsA dose.
${}^5$ Patients who received a treatment with a mycophenolic acid derivative at the end of the follow up phase.
${}^6$ Patients 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 $\ge$3%.