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NCT00098774 · OUTCOME

Change From Baseline in Mini-Mental Status Evaluation at 4 Months

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma · Source last updated 2016-07-06

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

Measure
MEDIAN
Unit
units on a scale
Interval / dispersion
Full Range
Time frame
Baseline & month 4

What was measured

Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.

Analysis population: Only 14 participants had both baseline and 4 month MMSE evaluations reported.

Groups in this outcome

Intensive Combination Chemo & Immunotherapy

Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)

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

Analysis denominator · Participants

GroupSource count
Intensive Combination Chemo & Immunotherapy14

Reported measurements

Baseline Score
Values in units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intensive Combination Chemo & Immunotherapy27Not reported730Not reported
4 month Score
Values in units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intensive Combination Chemo & Immunotherapy28Not reported2230Not reported
Change from Baseline
Values in units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intensive Combination Chemo & Immunotherapy1Not reported-118Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        30
        value
        27
    title
    Baseline Score
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        30
        value
        28
    title
    4 month Score
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        18
        value
        1
    title
    Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.
dispersion Type
Full Range
groups
  1. description
    Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
    id
    OG000
    title
    Intensive Combination Chemo & Immunotherapy
param Type
MEDIAN
population Description
Only 14 participants had both baseline and 4 month MMSE evaluations reported.
reporting Status
POSTED
time Frame
Baseline & month 4
title
Change From Baseline in Mini-Mental Status Evaluation at 4 Months
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice