Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00509249 · OUTCOME

Hematological Response Rate

Aflibercept in Treating Patients With Myelodysplastic Syndromes · Source last updated 2015-01-08

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 3 years

What was measured

Complete Response (CR): repeat bone marrow (BM) shows \<5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (\>110 g/L), neutrophils (≥1.0x10\^9/L), platelets (≥100x10\^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still \> 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.

Groups in this outcome

Arm I

Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies

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 I18

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Complete Response (CR): repeat bone marrow (BM) shows \<5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (\>110 g/L), neutrophils (≥1.0x10\^9/L), platelets (≥100x10\^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still \> 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.
groups
  1. description
    Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
    id
    OG000
    title
    Arm I
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 3 years
title
Hematological Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice