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NCT00274781 · OUTCOME

Tolerability

Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes · Source last updated 2015-07-10

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
12 Weeks

What was measured

Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.

Groups in this outcome

ATO (0.25mg/kg) and GO (3mg/m2)

ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.

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

Analysis denominator · Participants

GroupSource count
ATO (0.25mg/kg) and GO (3mg/m2)30

Reported measurements

Patients Who Completed 1 12-Week Cycle (C1)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)17Not reportedNot reportedNot reportedNot reported
Patients Who Completed 2 12-Week Cycles (C2)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)7Not reportedNot reportedNot reportedNot reported
Discontinue Tx During C1: Patient/Physician Choice
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)5Not reportedNot reportedNot reportedNot reported
Discontinue Tx During C1: Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)5Not reportedNot reportedNot reportedNot reported
Discontinue Tx During C1:Treatment Toxicity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)3Not reportedNot reportedNot reportedNot reported
Discontinue Tx After C1: Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)8Not reportedNot reportedNot reportedNot reported
Discontinue Tx After C1: Treatment Toxicity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ATO (0.25mg/kg) and GO (3mg/m2)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Patients Who Completed 1 12-Week Cycle (C1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Patients Who Completed 2 12-Week Cycles (C2)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Discontinue Tx During C1: Patient/Physician Choice
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Discontinue Tx During C1: Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Discontinue Tx During C1:Treatment Toxicity
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Discontinue Tx After C1: Progressive Disease
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Discontinue Tx After C1: Treatment Toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.
groups
  1. description
    ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
    id
    OG000
    title
    ATO (0.25mg/kg) and GO (3mg/m2)
param Type
NUMBER
reporting Status
POSTED
time Frame
12 Weeks
title
Tolerability
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice