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NCT03817853 · OUTCOME

Percentage of IRRs Regardless of Grade 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
Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)

What was measured

IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator.

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

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
All Participants113
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants50.4Not reportedNot reportedNot reportedNot reported
Cycle 1 Day 2

Analysis denominator · Participants

GroupSource count
All Participants51
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants7.8Not reportedNot reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
All Participants112
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants5.4Not reportedNot reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
All Participants111
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants4.5Not reportedNot reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
All Participants110
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants11.8Not reportedNot reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
All Participants108
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants8.3Not reportedNot reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
All Participants108
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants6.5Not reportedNot reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
All Participants107
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants5.6Not reportedNot reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
All Participants105
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants4.8Not reportedNot reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
All Participants55
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants3.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        113
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 Day 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      units
      Participants
    title
    Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    Cycle 1 Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    Cycle 2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      units
      Participants
    title
    Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      units
      Participants
    title
    Cycle 4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Cycle 5
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        105
      units
      Participants
    title
    Cycle 6
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Cycle 7
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    units
    Participants
description
IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator.
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.
reporting Status
POSTED
time Frame
Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)
title
Percentage of IRRs Regardless of Grade by Cycle
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice