22 November 2022: Original Paper
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipients with Hepatocellular Carcinoma
Gonzalo Sapisochin 1ADE** , Wei Chen Lee 2ABCDE , Dong Jin Joo 3ABD , Jae-Won Joh 4ABE , Koichiro Hata 56BCDE , Arvinder Singh Soin 7ACDE , Uday Kiran Veldandi 8ABCDEF , Shuhei Kaneko 9ACDE , Matthias Meier 10ACDEG , Denise Leclair 11DE , Gangadhar Sunkara 11CDEF , Long Bin Jeng 12AB**DOI: 10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
Table 7 Safety events for the patients who entered in H2406 in the AT population.
| AEs by PT | EVR+rTAC N=39n (%) | sTAC N=43n (%) |
|---|---|---|
| Subjects with at least one AE | 16 (41.0) | 23 (53.5) |
| Subjects with SAEs | 3 (7.7) | 6 (14.0) |
| AEs (≥3% in any group) | ||
| Abdominal pain | 0 | 2 (4.7) |
| Dental caries | 2 (5.1) | 1 (2.3) |
| Diarrhea | 2 (5.1) | 0 |
| Nasopharyngitis | 1 (2.6) | 2 (4.7) |
| Sinusitis | 0 | 2 (4.7) |
| Upper respiratory tract infection | 1 (2.6) | 4 (9.3) |
| Increased hepatic enzyme | 2 (5.1) | 0 |
| Osteoarthritis | 0 | 2 (4.7) |
| Chronic kidney diseases | 0 | 2 (4.7) |
| Cough | 0 | 2 (4.7) |
| Treatment-emergent AEs/infections were defined as any events starting on or after the first dose of immunosuppressant drug during the prospective period or before the last dose +7 days or events present prior to the start of the study but increased in severity after entering in this study. AE – adverse events; AT – as treated; EVR – everolimus; n – number of patients with events; N – the total number of patients in the treatment group; PT – preferred term; rTAC – reduced tacrolimus; SAE – serious adverse events; sTAC – standard dose tacrolimus. | ||