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NCT00644189 · OUTCOME

All Phase I-II Participants: Safety

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma · Source last updated 2023-03-15

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
during 6 28-day cycles and 90 days out

What was measured

Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)

Analysis population: all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine

Groups in this outcome

Clofarabine

Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

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

Analysis denominator · Participants

GroupSource count
Clofarabine50

Reported measurements

Any grade 3-4 toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clofarabine29Not reportedNot reportedNot reportedNot reported
Leukopenia and neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clofarabine24Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clofarabine15Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clofarabine7Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clofarabine3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Any grade 3-4 toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Leukopenia and neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Thrombocytopenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
groups
  1. description
    Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles. Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
    id
    OG000
    title
    Clofarabine
param Type
COUNT_OF_PARTICIPANTS
population Description
all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine
reporting Status
POSTED
time Frame
during 6 28-day cycles and 90 days out
title
All Phase I-II Participants: Safety
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice