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NCT00711828 · OUTCOME

Time to Treatment Failure

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

Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.

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
Treatment21

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment6.6Not reported211.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        11.6
        value
        6.6
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.
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
reporting Status
POSTED
time Frame
Up to 3 years from registration
title
Time to Treatment Failure
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice