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NCT00644189 · OUTCOME

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

Analysis population: Phase I participants only

Groups in this outcome

Phase I

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
Phase I30

Reported measurements

Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I19Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I18Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I9Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I8Not reportedNot reportedNot reportedNot reported
Neutropenic fever
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I1Not reportedNot reportedNot reportedNot reported
Grade 3-4 infections
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I3Not reportedNot reportedNot reportedNot reported
Any grade 3-4 toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Thrombocytopenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutropenic fever
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 3-4 infections
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Any grade 3-4 toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)
groups
  1. description
    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
    Phase I
param Type
COUNT_OF_PARTICIPANTS
population Description
Phase I participants only
reporting Status
POSTED
time Frame
during 6 28-day cycles and 90 days out
title
Phase I Participants: Safety
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice