Subgroup analysis of the incidence of ADR occurring during 28 weeks of treatment with tacrolimus (safety analysis set).
| Patient Characteristics at Baseline | N | Infections, n (%) | P | Renal Disorders, n (%) | P | Glucose Tolerance Disorders, n (%) | P | |
|---|---|---|---|---|---|---|---|---|
| Therapy setting | Inpatients | 306 | 39 (12.8) | 0.134∗ | 20 (6.5) | 0.039∗ | 19 (6.2) | 0.004∗ |
| Outpatients | 1049 | 101 (9.6) | 39 (3.7) | 27 (2.6) | ||||
| Age, yrs | < 15 | 25 | 3 (12.0) | 0.054# | 0 | 0.006# | 0 | 0.015# |
| 15–29 | 352 | 32 (9.1) | 10 (2.8) | 6 (1.7) | ||||
| 30–39 | 399 | 36 (9.0) | 17 (4.3) | 13 (3.3) | ||||
| 40–49 | 296 | 35 (11.8) | 12 (4.1) | 14 (4.7) | ||||
| 50–64 | 229 | 20 (8.7) | 15 (6.6) | 10 (4.4) | ||||
| > 65 | 54 | 14 (25.9) | 5 (9.3) | 3 (5.6) | ||||
| BMI, kg/m2 | < 25 | 798 | 86 (10.8) | 0.635# | 37 (4.6) | 0.954# | 24 (3.0) | 0.031# |
| 25–30 | 148 | 18 (12.2) | 7 (4.7) | 9 (6.1) | ||||
| > 30 | 42 | 5 (11.9) | 2 (4.8) | 3 (7.1) | ||||
| Concomitant disease | Absence | 166 | 7 (4.3) | 0.006∗ | 4 (2.5) | 0.302∗ | 2 (1.2) | 0.160∗ |
| Presence | 1192 | 133 (11.2) | 55 (4.6) | 44 (3.7) | ||||
| Previous disease | Absence | 931 | 80 (8.6) | 0.008∗ | 33 (3.5) | 0.065∗ | 28 (3.0) | 0.234∗ |
| Presence | 366 | 50 (13.7) | 22 (6.0) | 16 (4.4) | ||||
| Liver function | Normal | 1256 | 128 (10.2) | 0.486∗ | 54 (4.3) | 0.605∗ | 35 (2.8) | <0.001∗ |
| Abnormal | 96 | 12 (12.5) | 5 (5.2) | 11 (11.5) | ||||
| Renal function | Normal | 1061 | 104 (9.8) | 0.233∗ | 29 (2.7) | < 0.001∗ | 35 (3.3) | 0.716∗ |
| Abnormal | 293 | 36 (12.3) | 30 (10.2) | 11 (3.8) | ||||
| Cardiac function | Normal | 1271 | 128 (10.1) | 0.118∗ | 52 (4.1) | 0.037∗ | 40 (3.1) | 0.121∗ |
| Abnormal | 58 | 10 (17.2) | 6 (10.3) | 4 (6.9) | ||||
| Urinary protein, qualitative | – | 322 | 31 (9.6) | 0.156# | 5 (1.6) | 0.003# | 8 (2.5) | 0.616# |
| ± | 128 | 11 (8.6) | 4 (3.1) | 4 (3.1) | ||||
| + | 217 | 16 (7.4) | 11 (5.1) | 12 (5.5) | ||||
| ++ | 279 | 31 (11.1) | 14 (5.0) | 10 (3.6) | ||||
| 3+, 4+ | 291 | 37 (12.7) | 18 (6.2) | 9 (3.1) | ||||
| Urinary erythrocyte count, | – | 547 | 35 (6.4) | < 0.001# | 18 (3.3) | 0.264# | 17 (3.1) | 0.992# |
| qualitative | ± | 151 | 19 (12.6) | 11 (7.3) | 7 (4.6) | |||
| + | 198 | 27 (13.6) | 8 (4.0) | 8 (4.0) | ||||
| ++ | 152 | 25 (16.4) | 6 (3.9) | 6 (3.9) | ||||
| 3+, 4+ | 129 | 15 (11.6) | 8 (6.2) | 3 (2.3) | ||||
| Serum creatinine, mg/dL | < 0.8 | 944 | 100 (10.6) | 0.976# | 27 (2.9) | < 0.001# | 30 (3.2) | 0.523# |
| 0.8–1.1 | 232 | 21 (9.1) | 14 (6.0) | 9 (3.9) | ||||
| 1.2–1.5 | 90 | 9 (10.0) | 9 (10.0) | 5 (5.6) | ||||
| > 1.6 | 45 | 6 (13.3) | 9 (20.0) | 1 (2.2) | ||||
| TAC daily dose, mg/d | <3 | 788 | 81 (10.3) | 0.986# | 40 (5.1) | 0.150# | 23 (2.9) | 0.095# |
| 3 | 541 | 57 (10.5) | 18 (3.3) | 20 (3.7) | ||||
| >3 | 25 | 2 (8.0) | 1 (4.0) | 3 (12.0) | ||||
| TAC blood trough concentration, ng/mL | <5 | 692 | 51 (7.4) | 0.243# | 26 (3.7) | 0.169# | 17 (2.4) | 0.038# |
| 5 to < 10 | 271 | 21 (7.8) | 11 (4.0) | 14 (5.1) | ||||
| 10 to < 15 | 20 | 4 (20.0) | 3 (15.0) | 1 (4.8) | ||||
↵∗Fisher exact test.
↵#Cochran-Armitage test for trend. The subgroup analyses were performed for the incidences of common ADR occurring during the first 28-weeks of treatment with tacrolimus. The incidence of infections, renal disorders, and glucose tolerance disorders were analyzed as common ADR. (-): negative; (±): pseudo-positive; (+): positive; (++): double positive; (3+/4+): strong positive; ADR: adverse drug reactions; TAC: tacrolimus.