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NCT00924040 · OUTCOME

Percentage of Patients Who Have Dose Limiting Toxicity (DLT)

Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2015-10-29

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
24 weeks

What was measured

Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.

Groups in this outcome

BL22 Immunotherapy

30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.

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

Analysis denominator · Participants

GroupSource count
BL22 Immunotherapy1

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BL22 Immunotherapy0Not 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
      1
    units
    Participants
description
Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.
groups
  1. description
    30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
    id
    OG000
    title
    BL22 Immunotherapy
param Type
NUMBER
reporting Status
POSTED
time Frame
24 weeks
title
Percentage of Patients Who Have Dose Limiting Toxicity (DLT)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice