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NCT00240162 · OUTCOME

Safety and Tolerability of PTK787/ZK 222584

PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma · Source last updated 2014-09-17

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

Measure
NUMBER
Unit
adverse events
Interval / dispersion
Not reported
Time frame
30 days after treatment ends [median of 15 cycles (11-32)]

What was measured

Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.

Analysis population: Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.

Groups in this outcome

PTK787/ZK 222584

Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.

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

Analysis denominator · Participants

GroupSource count
PTK787/ZK 22258421

Reported measurements

Gastrointestinal toxicity
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTK787/ZK 2225848Not reportedNot reportedNot reportedNot reported
Neurologic toxicity
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTK787/ZK 2225845Not reportedNot reportedNot reportedNot reported
Cardiac toxicity
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTK787/ZK 2225844Not reportedNot reportedNot reportedNot reported
Hematological toxicity
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTK787/ZK 2225843Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Gastrointestinal toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Neurologic toxicity
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Cardiac toxicity
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hematological toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.
groups
  1. description
    Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
    id
    OG000
    title
    PTK787/ZK 222584
param Type
NUMBER
population Description
Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.
reporting Status
POSTED
time Frame
30 days after treatment ends [median of 15 cycles (11-32)]
title
Safety and Tolerability of PTK787/ZK 222584
type
SECONDARY
unit Of Measure
adverse events

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

Preserved source evidence · Not medical advice