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. Author manuscript; available in PMC: 2019 May 1.
Published in final edited form as: Hum Immunol. 2017 Oct 31;79(5):314–321. doi: 10.1016/j.humimm.2017.10.017

Table 2.

Primary endpoints

A. Safety: will be determined by assessing the proportion of subjects who experience the following events:

  1. CTCAE* Grade 4 or higher infusion reaction

  2. CTCAE Grade 4 or higher infection

  3. Malignancy other than non-melanoma skin cancer or HCC recurrence

  4. Rejection resulting in recipient death or re-transplantation

  5. Biopsy-proven severe acute rejection

  6. Any grade chronic rejection

  7. Non-surgical graft loss

  8. Recipient death

B. Preliminary Efficacy: will be determined by the proportion of patients able to achieve staged IS withdrawal and operational tolerance 1 yr after complete IS cessation based on liver biopsy criteria of the 2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology [63]
*

Common Terminology Criteria for Adverse Events