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NCT01226472 · OUTCOME

Number of Participants With Adverse Events as a Measure of Safety and Tolerability.

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
one year

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

With Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07611Not reportedNot reportedNot reportedNot reported
With Any Drug-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07610Not reportedNot reportedNot reportedNot reported
With Any TEAE with an Outcome of Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07610Not reportedNot reportedNot reportedNot reported
With Any Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07610Not reportedNot reportedNot reportedNot reported
With Any Drug-related Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07610Not reportedNot reportedNot reportedNot reported
With Any Serious TEAE with an Outcome of Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-07610Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    With Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    With Any Drug-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    With Any TEAE with an Outcome of Death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    With Any Serious TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    With Any Drug-related Serious TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    With Any Serious TEAE with an Outcome of Death
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
one year
title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice