Table 3

Summary chart of visits (experimental group)

Procedures
experimental group
Visit 1
(first 30 days)
Visit 2 to Visit 3
(month +1 to +2)
Visit 4 to Visit 13
(month +3 to +12)
Visit 14 and Visit 15
(month +15 and +18)
Informed consentX
Inclusion/exclusion criteriaX
RandomisationX
Medical history/anamnesisXXXX
Physical examination*XXXX
Pregnancy testX
Antiviral prophylaxisXXX
CMV PCR ‡,§XX
QF-CMV sample§X
Haemogram/biochemistryXXXX
Adverse events/concomitant medicationXXXX
  • *Physical examination: weight, heart rate, blood pressure, temperature, abdominal palpation and presence of edemas

  • †In month +3 post-transplant, the patient will continue with antiviral prophylaxis depending on the QF-CMV results.

  • ‡CMV PCR will be compulsory when antiviral prophylaxis is discontinued. The first CMV PCR will coincide with the day prophylaxis is discontinued and will be taken as a baseline determination.

  • §At Visits 14 and 15 it will not be compulsory to draw samples for viral load or for QF-CMV (unless indicated according to the center’s clinical practice)

  • ¶Haemogram: red blood cells, haemoglobin, leukocytes, neutrophils and platelets. Biochemistry: alkaline phosphatase, gamma-glutamyltransferase, alanine aminotransferase, aspartate aminotransferase, C-reactive protein, bilirubin, albumin and creatinin

  • CMV, cytomegalovirus; PCR, polymerase chain reaction; QF-CMV, QuantiFERON-CMV.