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NCT00112723 · OUTCOME

Qualitative and Quantitative Toxicities in Regard to Organ Specificity

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2016-08-08

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 30 days after completion of study treatment

What was measured

The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.

Analysis population: Grade 3 and 4 toxicities.

Groups in this outcome

Dose Levels 1, 2, 3

Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2) PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV

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

Analysis denominator · Participants

GroupSource count
Dose Levels 1, 2, 335

Reported measurements

Leukopenia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Levels 1, 2, 386Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Levels 1, 2, 323Not reportedNot reportedNot reportedNot reported
Infection
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Levels 1, 2, 320Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Levels 1, 2, 351Not reportedNot reportedNot reportedNot reported
Fatigue
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Levels 1, 2, 334Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        86
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Infection
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        51
    title
    Diarrhea
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
groups
  1. description
    Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2) PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
    id
    OG000
    title
    Dose Levels 1, 2, 3
param Type
NUMBER
population Description
Grade 3 and 4 toxicities.
reporting Status
POSTED
time Frame
Up to 30 days after completion of study treatment
title
Qualitative and Quantitative Toxicities in Regard to Organ Specificity
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice