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NCT01215344 · OUTCOME

Progression Free Survival by MRD Status at Day 100.

First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade · Source last updated 2018-05-15

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
up to 7 years

What was measured

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Analysis population: Patients with MRD status information at the EOI and day 100 (post-AHCT).

Groups in this outcome

MRD Negative at Day 100

Patients with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.

MRD Status Positive at Day 100 (Post-AHCT)

Patients with MRD status stay positive at both EOI and day 100.

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

Analysis denominator · Participants

GroupSource count
MRD Negative at Day 10013
MRD Status Positive at Day 100 (Post-AHCT)7

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MRD Negative at Day 1002.64Not reported0.73NAThe value is not estimable.
MRD Status Positive at Day 100 (Post-AHCT)NANot reportedNANAThese values are not estimable because no event happened yet.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The value is not estimable.
        group Id
        OG000
        lower Limit
        0.73
        upper Limit
        NA
        value
        2.64
      2. comment
        These values are not estimable because no event happened yet.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with MRD status negative at day 100 (post-AHCT). They have MRD negative or positve at EOI.
    id
    OG000
    title
    MRD Negative at Day 100
  2. description
    Patients with MRD status stay positive at both EOI and day 100.
    id
    OG001
    title
    MRD Status Positive at Day 100 (Post-AHCT)
param Type
MEDIAN
population Description
Patients with MRD status information at the EOI and day 100 (post-AHCT).
reporting Status
POSTED
time Frame
up to 7 years
title
Progression Free Survival by MRD Status at Day 100.
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice