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NCT03397706 · OUTCOME

Number (Proportion) of Participants With Adverse Events (AEs)

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies · Source last updated 2025-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 2 years

What was measured

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

Analysis 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.

Groups in this outcome

Phase 1b Dose Escalation Cohort 1

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 (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)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation Cohort 17
Phase 1b Dose Escalation Cohort 2a5
Phase 1b Dose Escalation Cohort 2b4
Phase 1b Dose Escalation Cohort 2c4
Phase 1b Dose Escalation Cohort 35
Phase 2 Dose Expansion - Capsule30
Phase 2 Dose Expansion - Tablet9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 17Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a5Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b4Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c4Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Capsule30Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Tablet9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        30
      7. group Id
        OG006
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      30
    7. group Id
      OG006
      value
      9
    units
    Participants
description
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
groups
  1. description
    VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    OG000
    title
    Phase 1b Dose Escalation Cohort 1
  2. description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    OG001
    title
    Phase 1b Dose Escalation Cohort 2a
  3. description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    OG002
    title
    Phase 1b Dose Escalation Cohort 2b
  4. description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    OG003
    title
    Phase 1b Dose Escalation Cohort 2c
  5. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG004
    title
    Phase 1b Dose Escalation Cohort 3
  6. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG005
    title
    Phase 2 Dose Expansion - Capsule
  7. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG006
    title
    Phase 2 Dose Expansion - Tablet
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Number (Proportion) of Participants With Adverse Events (AEs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice