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NCT01335685 · OUTCOME

Overall Survival (Phase 2)

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

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 date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)

What was measured

Overall Survival is the time in months from start of study treatment to date of death due to any cause.

Analysis population: The safety population consisted of participants who received at least 1 dose of any study drug.

Groups in this outcome

Arm B: Ixazomib 4.0 mg (RP2D)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).

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

Analysis denominator · Participants

GroupSource count
Arm B: Ixazomib 4.0 mg (RP2D)26

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B: Ixazomib 4.0 mg (RP2D)NANot reported34.99NAMedian and lower limit of CI was not reached due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and lower limit of CI was not reached due to low number of participants with events.
        group Id
        OG000
        lower Limit
        34.99
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Overall Survival is the time in months from start of study treatment to date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
    id
    OG000
    title
    Arm B: Ixazomib 4.0 mg (RP2D)
param Type
MEDIAN
population Description
The safety population consisted of participants who received at least 1 dose of any study drug.
reporting Status
POSTED
time Frame
From date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)
title
Overall Survival (Phase 2)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice