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NCT05012397 · OUTCOME

Progression-free Survival (PFS)

Milademetan in Advanced/Metastatic Solid Tumors · Source last updated 2024-10-17

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose date to the earliest date of recurrence, progression, death, or study completion; up to 23.5 months

What was measured

PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment

Analysis population: The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).

Groups in this outcome

Milademetan (RAIN-32)

260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle

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

Analysis denominator · Participants

GroupSource count
Milademetan (RAIN-32)31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Milademetan (RAIN-32)3.5Not reported1.83.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        3.7
        value
        3.5
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment
dispersion Type
95% Confidence Interval
groups
  1. description
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    id
    OG000
    title
    Milademetan (RAIN-32)
param Type
MEDIAN
population Description
The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).
reporting Status
POSTED
time Frame
From the first dose date to the earliest date of recurrence, progression, death, or study completion; up to 23.5 months
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice