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NCT01226472 · OUTCOME

Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging

Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001 · Source last updated 2024-04-25

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

Measure
NUMBER
Unit
days
Interval / dispersion
Not reported
Time frame
one year

Analysis population: Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).

Groups in this outcome

KW-0761

KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.

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

Analysis denominator · Participants

GroupSource count
KW-07611

Reported measurements

Progression-Free Survival (PFS)
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761260Not reportedNot reportedNot reportedNot reported
Time to Progression (TTP)
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761260Not reportedNot reportedNot reportedNot reported
Duration of Overall Response (DR)
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761232Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        260
    title
    Progression-Free Survival (PFS)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        260
    title
    Time to Progression (TTP)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        232
    title
    Duration of Overall Response (DR)
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
groups
  1. description
    KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
    id
    OG000
    title
    KW-0761
param Type
NUMBER
population Description
Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).
reporting Status
POSTED
time Frame
one year
title
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice