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NCT01399372 · OUTCOME

Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma · Source last updated 2023-07-20

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
At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 7.3 years.

What was measured

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events reported as definitely, probably, or possibly related to protocol treatment are considered to be related to treatment.

Analysis population: Eligible participants who started protocol treatment

Groups in this outcome

Chemotherapy

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.

Chemotherapy + Low-Dose WBRT

Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.

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

Analysis denominator · Participants

GroupSource count
Chemotherapy43
Chemotherapy + Low-Dose WBRT43

Reported measurements

Source class 1

None

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy2Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT3Not reportedNot reportedNot reportedNot reported

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy3Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT6Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy4Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT5Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy20Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT15Not reportedNot reportedNot reportedNot reported

Grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy14Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT13Not reportedNot reportedNot reportedNot reported

Grade 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Chemotherapy + Low-Dose WBRT1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      title
      None
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      title
      Grade 1
    3. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      title
      Grade 2
    4. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        15
      title
      Grade 3
    5. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        13
      title
      Grade 4
    6. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      title
      Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events reported as definitely, probably, or possibly related to protocol treatment are considered to be related to treatment.
groups
  1. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG000
    title
    Chemotherapy
  2. description
    Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
    id
    OG001
    title
    Chemotherapy + Low-Dose WBRT
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible participants who started protocol treatment
reporting Status
POSTED
time Frame
At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 7.3 years.
title
Distribution of Participants by Highest Grade Adverse Event Related to Protocol Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice