A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Solid Organ Transplant (SOT) Recipients in Europe and Canada (OTUS SOT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Italy, Netherlands, Poland and Sweden)

The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts.

No study medicines will be provided to participants in this study.

This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an SOT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an SOT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow-up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).

Inclusion Criteria:

(Cohort 1) Resistant / Refractory or Intolerant:

1. Aged greater than or equal to (>=) 18 years at the time of the SOT.

2. Received an SOT after January 1, 2016.

3. Diagnosed with asymptomatic or symptomatic CMV infection any time after the SOT date.

4. Required >=1 anti-CMV agent to manage CMV infection and were subsequently considered:

   1. resistant to currently available anti-CMV agent; OR
   2. refractory to currently available anti-CMV agent; OR
   3. intolerant to currently available anti-CMV agent.

5. Follow-up information is available for at least 12 months from the index date (that is, date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.

6. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the Institutional Ethical Committee [IEC]).

(Cohort 2) Pre-emptive treatment for CMV viremia:

1. Aged >=18 years at the time of the SOT.
2. Received an SOT after January 1, 2019.
3. Diagnosed with CMV viremia any time after the SOT date and received pre-emptive anti-CMV agent.
4. Follow-up information is available for at least 12 months from the index date (that is, date when the participant was first preemptively treated with an anti-CMV agent) or death, whichever occurs first.
5. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the IEC).

Exclusion Criteria: (Cohorts 1 and 2)

1. Diagnosed as being positive for human immunodeficiency virus before the SOT.
2. Unable to demonstrate a minimum of 12 months of follow-up from the index date (example, incomplete information on dates showing follow-up time).
3. Participation in a clinical trial related to CMV treatment during the study period .