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NCT03817853 · OUTCOME

Duration (In Minutes) of Obinutuzumab Administration 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 of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration.

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(C) 1 Day(D) 1

Analysis denominator · Participants

GroupSource count
All Participants100
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants295.96147.87Not reportedNot reportedNot reported
C1D8

Analysis denominator · Participants

GroupSource count
All Participants107
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants215.9746.99Not reportedNot reportedNot reported
C1D15

Analysis denominator · Participants

GroupSource count
All Participants102
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants208.9133.13Not reportedNot reportedNot reported
C2

Analysis denominator · Participants

GroupSource count
All Participants103
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants99.6113.36Not reportedNot reportedNot reported
C3

Analysis denominator · Participants

GroupSource count
All Participants101
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants103.2965.45Not reportedNot reportedNot reported
C4

Analysis denominator · Participants

GroupSource count
All Participants101
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants99.2613.90Not reportedNot reportedNot reported
C5

Analysis denominator · Participants

GroupSource count
All Participants100
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants98.4616.48Not reportedNot reportedNot reported
C6

Analysis denominator · Participants

GroupSource count
All Participants102
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants99.1012.18Not reportedNot reportedNot reported
C7

Analysis denominator · Participants

GroupSource count
All Participants51
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants98.8413.61Not reportedNot reportedNot reported
C8

Analysis denominator · Participants

GroupSource count
All Participants50
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants95.684.12Not reportedNot reportedNot reported
Maintenance Week 1

Analysis denominator · Participants

GroupSource count
All Participants83
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants97.6410.08Not reportedNot reportedNot reported
Maintenance Week 9

Analysis denominator · Participants

GroupSource count
All Participants63
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants96.788.49Not reportedNot reportedNot reported
Maintenance Week 17

Analysis denominator · Participants

GroupSource count
All Participants48
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants97.777.66Not reportedNot reportedNot reported
Maintenance Week 25

Analysis denominator · Participants

GroupSource count
All Participants31
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants97.167.23Not reportedNot reportedNot reported
Maintenance Week 33

Analysis denominator · Participants

GroupSource count
All Participants24
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants95.084.27Not reportedNot reportedNot reported
Maintenance Week 41

Analysis denominator · Participants

GroupSource count
All Participants13
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants95.775.26Not reportedNot reportedNot reported
Maintenance Week 49

Analysis denominator · Participants

GroupSource count
All Participants9
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants93.564.48Not reportedNot reportedNot reported
Maintenance Week 57

Analysis denominator · Participants

GroupSource count
All Participants2
Values in Minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants93.504.95Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        147.87
        value
        295.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    Cycle(C) 1 Day(D) 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.99
        value
        215.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    C1D8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.13
        value
        208.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    C1D15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.36
        value
        99.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      units
      Participants
    title
    C2
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.45
        value
        103.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      units
      Participants
    title
    C3
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.90
        value
        99.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      units
      Participants
    title
    C4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.48
        value
        98.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    C5
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.18
        value
        99.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    C6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.61
        value
        98.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    C7
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.12
        value
        95.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    C8
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.08
        value
        97.64
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      units
      Participants
    title
    Maintenance Week 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.49
        value
        96.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Maintenance Week 9
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    units
    Participants
description
The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration.
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 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 (In Minutes) of Obinutuzumab Administration by Cycle
type
SECONDARY
unit Of Measure
Minutes

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

Preserved source evidence · Not medical advice