MK-8228 (Letermovir) in the Prevention of Human Cytomegal... | NCT04129398

NCT04129398

ID	Type	Description	Link
MK-8228-042	Other Identifier	Merck Protocol Number
195020	Registry Identifier	JAPIC-CTI

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Letermovir	Experimental	Letermovir oral or intravenous (IV) formulation will be administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion will be administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.	Drug: Letermovir tablet Drug: Letermovir IV

Name	Type	Description	Arm Group Labels	Other Names
Letermovir tablet	Drug	A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks	Letermovir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Adverse Events (AEs)	Percentage of participants with one or more adverse events (AEs)	Up to week 52 post-transplant
Percentage of Participants Who Discontinued From Study Drug Due to an AE	Percentage of participants who discontinued from study drug due to an AE	Up to week 28 post-transplant

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Adjudicated CMV Disease or Undergone Anti-CMV Treatment	CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included. Participants who have undergone anti-CMV treatment was defined as initiation of approved anti-CMV agents based on at least one positive cell on CMV antigenemia and/or quantifiable CMV DNA PCR assay performed locally.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets recipient and/or donor CMV Immunoglobulin G (IgG) serostatus.
Anticipates receiving a primary or secondary allograft kidney at the time of screening and have received a primary or secondary allograft kidney at the time of allocation.
Is within 0 (i.e., day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of allocation.
Is a Japanese male or female from 18 years to any years of age inclusive, at the time of signing the informed consent.
Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP); but if a WOCBP, she is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse, and must have a negative highly sensitive pregnancy test within 72 hours before the first dose of study intervention.

Exclusion Criteria:

Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT).
Is a multi-organ transplant recipient (e.g., kidney-pancreas).
Has a history of CMV disease or suspected CMV disease within 6 months prior to allocation.
Has positive results on CMV assay and/or CMV antigen test at any time between the completion of the transplant surgery and time of allocation.
Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
Is on dialysis (for the purposes of this protocol dialysis includes hemofiltration) or plasmapheresis at the time of allocation.
Has Child-Pugh Class C severe hepatic insufficiency at screening.
Has post-transplant renal function of creatinine clearance (CrCl) ≤10 mL/min at allocation (measured locally).
Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
Has any uncontrolled infection on the day of allocation.
Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to allocation, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV RNA within 90 days prior to allocation or hepatitis B surface antigen (HBsAg) within 90 days prior to allocation.
Requires mechanical ventilation, or is hemodynamically unstable, at the time of allocation.
Has a history of malignancy ≤5 years prior to signing informed consent.
Has received within 30 days prior to allocation or plans to receive during the study any of the following: CMV immune globulin; any investigational CMV antiviral agent/biologic therapy.
Has received any dose of LET prior to allocation.
Has received within 7 days prior to allocation or plans to receive during the study any anti-CMV drug therapy.
Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
Is taking or plans to take any of the prohibited medications listed in the protocol.
Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound.
Has previously participated in this study or any other study involving LET.
Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 28 days following cessation of study therapy.
Is expecting to donate eggs starting from the time of consent through at least 28 days following cessation of study therapy.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital ( Site 0002)		Nagoya	Aichi-ken	466-8650	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38615067	Result	Ishida H, Goto N, Imamura R, Sasaki H, Unagami K, Futamura K, Murata Y, Oshima N, Eto T, Haber B. Letermovir safety and efficacy for cytomegalovirus prophylaxis in adult Japanese kidney transplant recipients: a multicenter, open-label, noncomparative Phase 3 study. Clin Exp Nephrol. 2024 Aug;28(8):822-831. doi: 10.1007/s10157-024-02471-0. Epub 2024 Apr 13.

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 1, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	BG00022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00048.5± 12.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006
Male	BG00016

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG00022

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG00022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Adverse Events (AEs)

Percentage of participants with one or more adverse events (AEs)

All participants who received at least one dose of study treatment.

Posted

Number

Percentage of Participants

Up to week 52 post-transplant

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

Title	Measurements
	OG00090.9

Primary

Percentage of Participants Who Discontinued From Study Drug Due to an AE

Percentage of participants who discontinued from study drug due to an AE

All participants who received at least one dose of treatment.

Posted

Number

Percentage of participants

Up to week 28 post-transplant

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adjudicated CMV Disease or Undergone Anti-CMV Treatment

CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included. Participants who have undergone anti-CMV treatment was defined as initiation of approved anti-CMV agents based on at least one positive cell on CMV antigenemia and/or quantifiable CMV DNA PCR assay performed locally.

All allocated participants who received at least one dose of study treatment, who were organ donor (D) or organ recipient (R) seropositive (D+/R-, D+/R+ or D-/R+) for Cytomegalovirus (CMV) and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to Week 52 post-transplant

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.
OG001	Letermovir D+/R-

Secondary

Percentage of Participants With Adjudicated CMV Disease

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to Week 52 post-transplant

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.
OG001	Letermovir D+/R-	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets. Letermovir D+/R- represents the D+/R- subgroup.

Secondary

Percentage of Participants With Quantifiable CMV DNAemia

Quantifiable CMV DNAemia (central) was defined as any case with a numeric value or >910,000,000 (not including reporting of PCR results as "detected, not quantifiable") using the Roche COBAS® AmpliPrep/COBAS TaqMan® (CAP/CTM) assay, which was performed by the central laboratory.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 52 post-transplant

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.
OG001	Letermovir D+/R-	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets. Letermovir D+/R- represents the D+/R- subgroup.

Secondary

Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of Plasma Letermovir-oral Treatment

AUCtau was defined as a measure of letermovir exposure that was calculated as the product of plasma drug concentration and time following an oral administration of letermovir.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable pharmacokinetic (PK) sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Trough Concentration (Ctrough) of Plasma Letermovir - Oral Treatment

Ctrough was defined as the minimum concentration of letermovir that occurred immediately following an oral administration of letermovir.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Any day between Days 6-10: 24hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Maximum Concentration (Cmax) of Plasma Letermovir - Oral Treatment

Cmax was defined as the maximum concentration of letermovir observed in plasma following an oral administration of letermovir.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Time to Reach Cmax (Tmax) of Plasma Letermovir - Oral Treatment

Tmax was defined as the time required post dosing to reach a maximum plasma concentration of letermovir following an oral administration of letermovir.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample.

Posted

Median

Full Range

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Apparent Clearance at Steady State (CLss/F) of Plasma Letermovir - Oral Treatment

Apparent clearance at steady state (CLss/F) of plasma letermovir following an oral administration of letermovir.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/hr

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of Plasma Letermovir - IV Treatment

AUCtau was defined as a measure of letermovir exposure that was calculated as the product of plasma drug concentration and time following an IV administration of letermovir was intended to measure.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample. None of the participants received letermovir IV.

Posted

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Trough Concentration (Ctrough) of Plasma Letermovir - IV Treatment

Ctrough was defined as the minimum concentration of letermovir that occurred immediately following an IV administration of letermovir was intended to measure.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample. None of the participants received letermovir IV.

Posted

Pre-dose on Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Concentration at the End of Infusion (Ceoi) of Plasma Letermovir - IV Treatment

Ceoi is defined as the amount of letermovir in plasma following an IV administration of letermovir was intended to measure.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample. None of the participants received letermovir IV.

Posted

Any day between Days 6-10: at end of infusion (1 hours post dose)

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Secondary

Clearance at Steady State (CLss) of Plasma Letermovir - IV Treatment

Clearance at steady state (CLss) of plasma letermovir following an IV administration of letermovir was intended to measure.

The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one measurable PK sample. None of the participants received letermovir IV.

Posted

Any day between Days 6-10: pre-dose, 1, 2.5, 5, 8 and 24 hrs post-dose

ID	Title	Description
OG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Letermovir	Letermovir oral or intravenous (IV) formulation was administered once daily for up to 28 weeks, beginning up to 7 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A (CsA) and 480 mg once daily for participants not receiving CsA. IV infusion was administered only to participants who were unable to swallow tablets or who had a condition that may have interfered with absorption of the tablets.	0	22	7	22	13	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Adenoviral haemorrhagic cystitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Herpes zoster	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Tonsillitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected22 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk
Lymphocele	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected22 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected22 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected22 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected22 at risk
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected22 at risk

ID	Term
D003586	Cytomegalovirus Infections

ID	Term
C000588473	letermovir

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections