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NCT03817853 · OUTCOME

Progression-Free Survival (PFS) Rate at the End of the Study

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma · Source last updated 2024-04-04

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
Baseline up to end of study (up to approximately 4 years)

What was measured

PFS was defined as the time from start of treatment to the first occurrence of disease progression as assessed by the investigator according to the guidelines used at the site or death from any cause.

Analysis population: The safety population included all participants who received at least one dose of obinutuzumab.

Groups in this outcome

All Participants

Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.

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

Analysis denominator · Participants

GroupSource count
All Participants113

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Participants33.97Not reported32.13NADue to the low number of events, the upper CI limit was not evaluable.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to the low number of events, the upper CI limit was not evaluable.
        group Id
        OG000
        lower Limit
        32.13
        upper Limit
        NA
        value
        33.97
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    units
    Participants
description
PFS was defined as the time from start of treatment to the first occurrence of disease progression as assessed by the investigator according to the guidelines used at the site or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
    id
    OG000
    title
    All Participants
param Type
MEDIAN
population Description
The safety population included all participants who received at least one dose of obinutuzumab.
reporting Status
POSTED
time Frame
Baseline up to end of study (up to approximately 4 years)
title
Progression-Free Survival (PFS) Rate at the End of the Study
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice