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NCT00719472 · OUTCOME

Duration of Rituximab Infusion Including Dose Interruption Times

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE) · Source last updated 2017-05-15

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

Measure
MEDIAN
Unit
Minutes
Interval / dispersion
Inter-Quartile Range
Time frame
Day 1 of each of Cycles 1 to 6 or 8

What was measured

The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.

Analysis population: Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.

Groups in this outcome

Rituximab 375 mg/m^2

Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.

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

Analysis denominator · Participants

GroupSource count
Rituximab 375 mg/m^2363

Reported measurements

Cycle 1 (n=362)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^2245Not reported225273Not reported
Cycle 2 (n=363)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9098Not reported
Cycle 3 (n=344)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9098Not reported
Cycle 4 (n=329)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9096Not reported
Cycle 5 (n=312)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9095Not reported
Cycle 6 (n=303)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9096Not reported
Cycle 7 (n=59)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9095Not reported
Cycle 8 (n=59)
Values in Minutes · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Rituximab 375 mg/m^291Not reported9095Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        225
        upper Limit
        273
        value
        245
    title
    Cycle 1 (n=362)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        98
        value
        91
    title
    Cycle 2 (n=363)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        98
        value
        91
    title
    Cycle 3 (n=344)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        96
        value
        91
    title
    Cycle 4 (n=329)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        95
        value
        91
    title
    Cycle 5 (n=312)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        96
        value
        91
    title
    Cycle 6 (n=303)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        95
        value
        91
    title
    Cycle 7 (n=59)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90
        upper Limit
        95
        value
        91
    title
    Cycle 8 (n=59)
denoms
  1. counts
    1. group Id
      OG000
      value
      363
    units
    Participants
description
The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
    id
    OG000
    title
    Rituximab 375 mg/m^2
param Type
MEDIAN
population Description
Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.
reporting Status
POSTED
time Frame
Day 1 of each of Cycles 1 to 6 or 8
title
Duration of Rituximab Infusion Including Dose Interruption Times
type
SECONDARY
unit Of Measure
Minutes

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice