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NCT00711828 · OUTCOME

Duration of Response

Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma · Source last updated 2019-04-16

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years from registration

What was measured

Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.

Analysis population: Thirteen patients achieved a CR or a PR and are included in this analysis.

Groups in this outcome

Treatment

Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22

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

Analysis denominator · Participants

GroupSource count
Treatment13

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment25.9Not reported8NAThe 95% upper confidence limit was not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The 95% upper confidence limit was not reached.
        group Id
        OG000
        lower Limit
        8
        upper Limit
        NA
        value
        25.9
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
    id
    OG000
    title
    Treatment
param Type
MEDIAN
population Description
Thirteen patients achieved a CR or a PR and are included in this analysis.
reporting Status
POSTED
time Frame
Up to 3 years from registration
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice