Trial Outcomes & Findings for Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies (NCT NCT03397706)

Last Updated: 2025-03-20

Results Overview

Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Up to approximately 2 years

Results posted on

2025-03-20

Participant Flow

Starting valganciclovir dosage reductions based on creatinine clearance were allowed for participants with renal impairment.

Participant milestones

Participant milestones
Measure	Phase 1b Dose Escalation Cohort 1 Viracta (VRx)-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week) and valganciclovir 900 mg QD	Phase 2 Expansion - Tablet VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week and valganciclovir 900 mg QD
Overall Study STARTED	7	5	4	4	5	30	9
Overall Study COMPLETED	7	5	4	4	5	30	9
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b Dose Escalation Cohort 1 n=7 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=5 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=4 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=30 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=9 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=8 Participants	3 Participants n=8 Participants	34 Participants n=24 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=8 Participants	6 Participants n=8 Participants	30 Participants n=24 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 24.06 • n=5 Participants	60.8 years STANDARD_DEVIATION 20.44 • n=7 Participants	45.3 years STANDARD_DEVIATION 19.45 • n=5 Participants	56.8 years STANDARD_DEVIATION 10.56 • n=4 Participants	44.0 years STANDARD_DEVIATION 24.36 • n=21 Participants	60.1 years STANDARD_DEVIATION 16.97 • n=8 Participants	63.4 years STANDARD_DEVIATION 15.42 • n=8 Participants	57.7 years STANDARD_DEVIATION 18.42 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	12 Participants n=8 Participants	4 Participants n=8 Participants	24 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	18 Participants n=8 Participants	5 Participants n=8 Participants	40 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants	1 Participants n=8 Participants	12 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	22 Participants n=8 Participants	7 Participants n=8 Participants	51 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	24 Participants n=8 Participants	8 Participants n=8 Participants	50 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	20 Participants n=8 Participants	9 Participants n=8 Participants	51 Participants n=24 Participants
Region of Enrollment Brazil	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=8 Participants	0 Participants n=8 Participants	13 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Peripheral T-cell Lymphoma / Angioimmunoblastic T-cell Lymphoma	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants	2 Participants n=8 Participants	13 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Diffuse Large B-cell Lymphoma	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	10 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Extranodal NK/T-cell Lymphoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	1 Participants n=8 Participants	10 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Human Immunodeficiency Virus-Associated Lymphoma	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Hodgkin Lymphoma	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	1 Participants n=8 Participants	12 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Immunodeficiency-Associated Lymphoproliferative Disorders	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Other B-cell Non-Hodgkin Lymphomas	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Other T-cell Non-Hodgkin Lymphomas	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants
Lymphoma or Lymphoproliferative Disorder Subtype Post-Transplant Lymphoproliferative Disorders	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=7 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=5 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=4 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=30 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=9 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Number (Proportion) of Participants With Adverse Events (AEs)	7 Participants	5 Participants	4 Participants	4 Participants	5 Participants	30 Participants	9 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria: * Grade 4 anemia unexplained by underlying disease * Grade 4 febrile neutropenia * Grade 4 neutropenia lasting \>5 days * Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration * Grade 4 or higher tumor lysis syndrome * Grade 3 or higher thrombocytopenia (with or without bleeding) * Any requirement for platelet transfusion * Grade 3 or higher non-hematologic toxicity despite adequate supportive care * Results in a dose hold of \>7 consecutive days

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=7 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=5 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=4 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the Lugano 2014 criteria (Cheson, Bruce D. et al. J Clin Oncology 2014;32(27):3059-68), where CR included complete metabolic response (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions, and PR included partial metabolic response (reduced FDG uptake compared with baseline) or radiologic response (target lesions ≤ 50% decrease in the sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=6 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=2 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=23 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=8 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Overall Response Rate Complete Response	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants
Overall Response Rate Partial Response	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	4 Participants	1 Participants
Overall Response Rate Stable Disease	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	5 Participants	1 Participants
Overall Response Rate Progressive Disease	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Patients who achieved a CR or PR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Interval of time from date of first observed complete or partial response per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) to the date of documented disease progression or death due to any cause, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=3 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=1 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=3 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=7 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=2 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Duration of Response	825.5 days Interval 160.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	116.5 days Interval 34.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	113.0 days The lower and upper bounds of the 95% confidence interval were not reached due to insufficient number of participants with events.	—	NA days Interval 127.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.	634.0 days Interval 80.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	NA days Interval 57.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Patients who achieved a PR or CR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Interval of time from the start of study drug treatment to the first documentation of CR or PR per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=3 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=1 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=3 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=7 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=2 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Time to Response	NA days Interval 33.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.	52.5 days Interval 51.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	NA days Interval 50.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.	—	NA days Interval 57.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.	162.0 days Interval 58.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	NA days Interval 58.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 2 years

Interval of time from the date of first study drug administration to the documented date of disease progression or death, whichever occurred first, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=6 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=2 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=23 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=8 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Progression-Free Survival	209.0 days Interval 57.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	168.0 days Interval 87.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	107.5 days Interval 53.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	55.5 days Interval 15.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	185.0 days Interval 10.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	66.0 days Interval 56.0 to 220.0	52.5 days Interval 34.0 to 114.0

SECONDARY outcome

Timeframe: Up to approximately 2 years

Number (percentage) of patients with CR, PR, or stable disease (SD) per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=6 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=2 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=23 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=8 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Disease Control Rate	4 Participants	2 Participants	1 Participants	1 Participants	4 Participants	12 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to approximately 2 years

Interval of time from date of first study drug treatment to date of death, for any reason (patients without documentation of death at the time of analysis were censored at the date the patient was last known to be alive)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=6 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=2 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=2 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=23 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=8 Participants VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Overall Survival	227.0 days Interval 122.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	578.0 days Interval 486.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	NA days Interval 328.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.	168.5 days Interval 32.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	496.0 days Interval 49.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	801.0 days Interval 315.0 to The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.	NA days Interval 106.0 to The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

Population: The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations.

Pharmacokinetic (PK) assessment of VRx-3996 pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on cycle 1 day 1 (C1D1) and cycle 2 day 2 (C2D1)

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=5 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=15 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=5 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=30 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=9 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Cmax (ng/mL) of VRx-3996 Single-dose	29.8 ng/mL Standard Deviation 26.7	83.3 ng/mL Standard Deviation 38.1	214 ng/mL Standard Deviation 140	196 ng/mL Standard Deviation 166	298 ng/mL Standard Deviation 137	—	—
Cmax (ng/mL) of VRx-3996 Multiple-dose	—	—	—	334 ng/mL Standard Deviation 283	238 ng/mL Standard Deviation 208	—	—

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=13 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=12 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=30 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=9 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Cmax (ng/mL) of Valganciclovir Single-Dose	4230 ng/mL Standard Deviation 1348	6712 ng/mL Standard Deviation 1495	7300 ng/mL Standard Deviation 2790	14900 ng/mL Standard Deviation 8380	—	—	—
Cmax (ng/mL) of Valganciclovir Multiple-Dose	—	—	8690 ng/mL Standard Deviation 5800	14200 ng/mL Standard Deviation 7060	—	—	—

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

PK assessment of VRx-3996 pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=5 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=15 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=5 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=30 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=9 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Area Under Curve (AUC) 0-t of VRx-3996 Single-dose	128 h*ng/mL Standard Deviation 67.0	229 h*ng/mL Standard Deviation 76.4	340 h*ng/mL Standard Deviation 384	417 h*ng/mL Standard Deviation 299	587 h*ng/mL Standard Deviation 212	—	—
Area Under Curve (AUC) 0-t of VRx-3996 Multiple-dose	—	—	—	638 h*ng/mL Standard Deviation 418	474 h*ng/mL Standard Deviation 268	—	—

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=13 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=12 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=30 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=9 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
AUC 0-t of of Valganciclovir Multiple-dose	—	—	28300 h*ng/mL Standard Deviation 16400	46600 h*ng/mL Standard Deviation 18000	—	—	—
AUC 0-t of of Valganciclovir Single-dose	15600 h*ng/mL Standard Deviation 4160	24400 h*ng/mL Standard Deviation 9300	25200 h*ng/mL Standard Deviation 10400	49700 h*ng/mL Standard Deviation 29100	—	—	—

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

PK assessment of VRx-3996 pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=5 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=15 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=5 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=30 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=9 Participants VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Half-life of VRx-3996 Single-dose	1.89 hours Standard Deviation 0.252	1.44 hours Standard Deviation 0.466	—	1.46 hours Standard Deviation 0.589	1.43 hours Standard Deviation 0.287	—	—
Half-life of VRx-3996 Multiple-dose	—	—	—	1.10 hours Standard Deviation 0.181	1.87 hours Standard Deviation 1.33	—	—

SECONDARY outcome

Timeframe: Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Outcome measures

Outcome measures
Measure	Phase 1b Dose Escalation Cohort 1 n=11 Participants VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=10 Participants VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=23 Participants VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=6 Participants VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Half-life of Valganciclovir Single-dose	3.56 hours Standard Deviation 1.06	3.13 hours Standard Deviation 1.43	3.32 hours Standard Deviation 1.10	2.17 hours Standard Deviation 1.68	—	—	—
Half-life of Valganciclovir Multiple-dose	—	—	2.43 hours Standard Deviation 0.697	2.61 hours Standard Deviation 1.55	—	—	—

Adverse Events

Phase 1b Dose Escalation Cohort 1

Serious events: 2 serious events

Other events: 7 other events

Deaths: 4 deaths

Phase 1b Dose Escalation Cohort 2a

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Phase 1b Dose Escalation Cohort 2b

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Phase 1b Dose Escalation Cohort 2c

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Phase 1b Dose Escalation Cohort 3

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

Phase 2 Dose Expansion - Capsule

Serious events: 11 serious events

Other events: 22 other events

Deaths: 17 deaths

Phase 2 Dose Expansion - Tablet

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b Dose Escalation Cohort 1 n=7 participants at risk VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=5 participants at risk VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=4 participants at risk VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 participants at risk VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 participants at risk VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=30 participants at risk VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=9 participants at risk VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Nervous system disorders Cerebrovascular accident	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Sepsis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Oral pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Pyrexia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Clostridium difficile infection	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Enterocolitis viral	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Pharyngitis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Pneumonia	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Cardiac disorders Atrial flutter	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Cardiac disorders Left ventricular failure	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Immune system disorders Drug hypersensitivity	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Metabolism and nutrition disorders Failure to thrive	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Vascular disorders Embolism	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Other adverse events

Other adverse events
Measure	Phase 1b Dose Escalation Cohort 1 n=7 participants at risk VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID	Phase 1b Dose Escalation Cohort 2a n=5 participants at risk VRx-3996: 5 mg BID valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2b n=4 participants at risk VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID	Phase 1b Dose Escalation Cohort 2c n=4 participants at risk VRx-3996: 10 mg QD valganciclovir: 900 mg QD	Phase 1b Dose Escalation Cohort 3 n=5 participants at risk VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD	Phase 2 Dose Expansion - Capsule n=30 participants at risk VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)	Phase 2 Dose Expansion - Tablet n=9 participants at risk VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Oral pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Thrombocytopenia	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	16.7% 5/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Constipation	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	80.0% 4/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	26.7% 8/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Diarrhoea	42.9% 3/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	23.3% 7/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	44.4% 4/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	75.0% 3/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 6/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	33.3% 3/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Dysphagia	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Toothache	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Fatigue	57.1% 4/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	33.3% 10/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	66.7% 6/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Pyrexia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 6/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Chills	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	13.3% 4/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Asthenia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Chest pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Oedema peripheral	57.1% 4/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Gait disturbance	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Injection site reaction	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Localised oedema	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Neutrophil count decreased	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	16.7% 5/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	33.3% 3/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Anaemia	42.9% 3/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	36.7% 11/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	44.4% 4/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Urinary tract infection	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	16.7% 5/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 6/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	13.3% 4/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Nervous system disorders Headache	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	75.0% 3/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Psychiatric disorders Insomnia	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Blood and lymphatic system disorders Neutropenia	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	50.0% 2/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	16.7% 5/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Nausea	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	75.0% 3/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	80.0% 4/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	36.7% 11/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	55.6% 5/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Gastrointestinal disorders Dry Mouth	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Blood creatinine increased	42.9% 3/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	60.0% 3/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Platelet count decreased	42.9% 3/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	33.3% 3/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations White blood cell count decreased	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	13.3% 4/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	33.3% 3/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Lymphocyte count decreased	28.6% 2/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Weight decreased	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	40.0% 2/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Investigations Blood bilirubin increased	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
General disorders Mucosal inflammation	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Acute sinusitis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	3.3% 1/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Oral candidiasis	14.3% 1/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Pharyngitis	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	25.0% 1/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Infections and infestations Pyoderma	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 6/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	10.0% 3/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	22.2% 2/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/7 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	0.00% 0/4 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	20.0% 1/5 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	6.7% 2/30 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.	11.1% 1/9 • Up to approximately 2 years Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Additional Information

Medical Director

Viracta Therapeutics

Phone: 858-400-8470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60