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NCT03817853 · OUTCOME

Type 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

Analysis population: The safety population included all participants who received at least one dose of obinutuzumab. Only 1 participant had a Grade \>=3 IRR, with 3 symptoms in Cycle 5. Weight increased was a grade 1 symptom belonging to the grade 3 IRRs.

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

Cycle (C) 5- Hypertension

Analysis denominator · Participants

GroupSource count
All Participants1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants33.3Not reportedNot reportedNot reportedNot reported
C5 - Renal failure

Analysis denominator · Participants

GroupSource count
All Participants1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants33.3Not reportedNot reportedNot reportedNot reported
C5 - Weight increased

Analysis denominator · Participants

GroupSource count
All Participants1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants33.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle (C) 5- Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    C5 - Renal failure
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    C5 - Weight increased
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    units
    Participants
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
NUMBER
population Description
The safety population included all participants who received at least one dose of obinutuzumab. Only 1 participant had a Grade \>=3 IRR, with 3 symptoms in Cycle 5. Weight increased was a grade 1 symptom belonging to the grade 3 IRRs.
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
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice