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NCT02989857 · OUTCOME

Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years)

Analysis population: SAS included all participants who received at least one dose of study drug (AG-120 or Placebo).

Groups in this outcome

AG-120

Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.

Placebo

Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.

After Crossover to AG-120

Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.

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

Analysis denominator · Participants

GroupSource count
AG-120123
Placebo59
After Crossover to AG-12043

Reported measurements

Electrocardiogram QT Prolonged
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1209.8Not reportedNot reportedNot reportedNot reported
Placebo3.4Not reportedNot reportedNot reportedNot reported
After Crossover to AG-1202.3Not reportedNot reportedNot reportedNot reported
Electrocardiogram Abnormal
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1200.8Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
After Crossover to AG-1200.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9.8
      2. group Id
        OG001
        value
        3.4
      3. group Id
        OG002
        value
        2.3
    title
    Electrocardiogram QT Prolonged
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
    title
    Electrocardiogram Abnormal
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      59
    3. group Id
      OG002
      value
      43
    units
    Participants
groups
  1. description
    Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
    id
    OG000
    title
    AG-120
  2. description
    Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
    id
    OG001
    title
    Placebo
  3. description
    Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.
    id
    OG002
    title
    After Crossover to AG-120
param Type
NUMBER
population Description
SAS included all participants who received at least one dose of study drug (AG-120 or Placebo).
reporting Status
POSTED
time Frame
Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years)
title
Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice