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NCT00072475 · OUTCOME

Progression-free Survival

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes · Source last updated 2016-08-01

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
Duration of study (up to 5 years)

What was measured

Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method. Progression is defined as * For patients with \<5% bone marrow blasts: ≥50% increase in blasts to \>5% blasts * For patients with 5-10% bone marrow blasts: ≥50% increase to \>10% blasts * For patients with 10-19% bone marrow blasts: increase to ≥20% blasts * One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC \< 1.5 K/L or PLT\< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent Progression after HI: Includes one or more of the following * Decrement of 50% or greater from maximum response levels in ANC \< 1.5 K/L or PLT \< 100 K/L * Reduction in HGB concentration by at least 2 g/dL * Becoming transfusion dependent

Groups in this outcome

Vatalanib

Adult patients with MDS receive treatment with vatalanib. vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

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

Analysis denominator · Participants

GroupSource count
Vatalanib142

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vatalanib10.2Not reported7.414.74Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.4
        upper Limit
        14.74
        value
        10.2
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    units
    Participants
description
Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method. Progression is defined as * For patients with \<5% bone marrow blasts: ≥50% increase in blasts to \>5% blasts * For patients with 5-10% bone marrow blasts: ≥50% increase to \>10% blasts * For patients with 10-19% bone marrow blasts: increase to ≥20% blasts * One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC \< 1.5 K/L or PLT\< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent Progression after HI: Includes one or more of the following * Decrement of 50% or greater from maximum response levels in ANC \< 1.5 K/L or PLT \< 100 K/L * Reduction in HGB concentration by at least 2 g/dL * Becoming transfusion dependent
dispersion Type
95% Confidence Interval
groups
  1. description
    Adult patients with MDS receive treatment with vatalanib. vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
    id
    OG000
    title
    Vatalanib
param Type
MEDIAN
reporting Status
POSTED
time Frame
Duration of study (up to 5 years)
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice