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NCT05654623 · OUTCOME

Number of Participants According to Categorization of QT Interval Corrected Using Fridericia's Formula (QTcF) Results-QTc Substudy Analysis Set

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18

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
Baseline and from the first dose of study treatment up to the end of treatment (EOT) i.e., 28 days after last dose of study treatment (approximately up to 19.56 months)

What was measured

Criteria for QTcF interval for single beat were as follows, \<= 450 msec, \> 450 to \<= 480 msec, \> 480 to \<=500 msec, \> 500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec, increase from baseline \> 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.

Analysis population: QTc substudy analysis set= subset of SAS participants in vepdegestrant (ARV-471) arm, randomized at selected sites and had ECG measurements to evaluate effect of ARV-471 on QTcF via serial triplicate ECGs (centrally read), had baseline ECG measurement (Cycle 1 Day 1 pre-dose) and at least one ECG measurement on Day 1 of Cycle 2 or Cycle 3 following \>= 7 consecutive days of 200 mg ARV-471. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

Vepdegestrant (ARV-471)

Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

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

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)88

Reported measurements

QTcF interval for single beat <=450 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)63Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat > 450 to <= 480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)24Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat >480 to <=500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)0Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat > 500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)1Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat increase from baseline <= 30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)67Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat increase from baseline >30 to <= 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)21Not reportedNot reportedNot reportedNot reported
QTcF interval for single beat increase from baseline > 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63
    title
    QTcF interval for single beat <=450 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    QTcF interval for single beat > 450 to <= 480 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    QTcF interval for single beat >480 to <=500 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    QTcF interval for single beat > 500 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        67
    title
    QTcF interval for single beat increase from baseline <= 30 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    QTcF interval for single beat increase from baseline >30 to <= 60 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    QTcF interval for single beat increase from baseline > 60 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
Criteria for QTcF interval for single beat were as follows, \<= 450 msec, \> 450 to \<= 480 msec, \> 480 to \<=500 msec, \> 500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec, increase from baseline \> 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.
groups
  1. description
    Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    OG000
    title
    Vepdegestrant (ARV-471)
param Type
COUNT_OF_PARTICIPANTS
population Description
QTc substudy analysis set= subset of SAS participants in vepdegestrant (ARV-471) arm, randomized at selected sites and had ECG measurements to evaluate effect of ARV-471 on QTcF via serial triplicate ECGs (centrally read), had baseline ECG measurement (Cycle 1 Day 1 pre-dose) and at least one ECG measurement on Day 1 of Cycle 2 or Cycle 3 following \>= 7 consecutive days of 200 mg ARV-471. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline and from the first dose of study treatment up to the end of treatment (EOT) i.e., 28 days after last dose of study treatment (approximately up to 19.56 months)
title
Number of Participants According to Categorization of QT Interval Corrected Using Fridericia's Formula (QTcF) Results-QTc Substudy Analysis Set
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice