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NCT03817853 · OUTCOME

Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle

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
MEAN
Unit
Minutes
Interval / dispersion
Standard Deviation
Time frame
All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

What was measured

The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI.

Analysis population: The safety population (113 participants) 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 Participants1

Reported measurements

Source class 1
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants165.0NANot reportedNot reportedSD is not available because only 1 participant had the duration of IRR recorded and the SD for one value is not defined.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        SD is not available because only 1 participant had the duration of IRR recorded and the SD for one value is not defined.
        group Id
        OG000
        spread
        NA
        value
        165.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI.
dispersion Type
Standard Deviation
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
MEAN
population Description
The safety population (113 participants) included all participants who received at least one dose of obinutuzumab.
reporting Status
POSTED
time Frame
All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
title
Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
type
SECONDARY
unit Of Measure
Minutes

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

Preserved source evidence · Not medical advice