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NCT01010061 · OUTCOME

European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
unit on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Cycle 4 Day 1 (Cy4D1)

What was measured

EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.

Analysis population: ITT population. Here, n signifies the number of participants who were evaluated for specified categories.

Groups in this outcome

Obinutuzumab + Chlorambucil (GClb)

Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

Chlorambucil (Clb)

Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil (GClb)238
Chlorambucil (Clb)118

Reported measurements

Disease Effects Scale: Baseline (n=209, 102)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)2318.89Not reportedNot reportedNot reported
Chlorambucil (Clb)23.720.18Not reportedNot reportedNot reported
Disease Effects Scale: Cy4D1 (n=176, 86)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)15.015.12Not reportedNot reportedNot reported
Chlorambucil (Clb)15.914.16Not reportedNot reportedNot reported
Fatigue Scale: Baseline (n=209, 102)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)31.225.83Not reportedNot reportedNot reported
Chlorambucil (Clb)27.624.65Not reportedNot reportedNot reported
Fatigue Scale: Cy4D1 (n=176, 86)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)20.921.51Not reportedNot reportedNot reported
Chlorambucil (Clb)23.422.20Not reportedNot reportedNot reported
Future Health: Baseline (n=206, 101)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)47.732.14Not reportedNot reportedNot reported
Chlorambucil (Clb)50.833.53Not reportedNot reportedNot reported
Future Health: Cy4D1 (n=175, 86)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)29.531.74Not reportedNot reportedNot reported
Chlorambucil (Clb)39.130.33Not reportedNot reportedNot reported
Infection Scale: Baseline (n=209, 102)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)1215.91Not reportedNot reportedNot reported
Chlorambucil (Clb)14.617.97Not reportedNot reportedNot reported
Infection Scale: Cy4D1 (n=176, 86)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)8.911.65Not reportedNot reportedNot reported
Chlorambucil (Clb)8.510.70Not reportedNot reportedNot reported
Social Problems: Baseline (n=206, 100)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)24.331.99Not reportedNot reportedNot reported
Chlorambucil (Clb)26.333.26Not reportedNot reportedNot reported
Social Problems: Cy4D1 (n=175, 85)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)19.427.75Not reportedNot reportedNot reported
Chlorambucil (Clb)22.027.00Not reportedNot reportedNot reported
Treatment Side Effects Scale: Baseline (n=209,102)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)19.817.7Not reportedNot reportedNot reported
Chlorambucil (Clb)17.215.27Not reportedNot reportedNot reported
Treatment Side Effect Scale: Cy4D1(n=176,86)
Values in unit on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)14.714.68Not reportedNot reportedNot reported
Chlorambucil (Clb)15.616.11Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.89
        value
        23
      2. group Id
        OG001
        spread
        20.18
        value
        23.7
    title
    Disease Effects Scale: Baseline (n=209, 102)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.12
        value
        15.0
      2. group Id
        OG001
        spread
        14.16
        value
        15.9
    title
    Disease Effects Scale: Cy4D1 (n=176, 86)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.83
        value
        31.2
      2. group Id
        OG001
        spread
        24.65
        value
        27.6
    title
    Fatigue Scale: Baseline (n=209, 102)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.51
        value
        20.9
      2. group Id
        OG001
        spread
        22.20
        value
        23.4
    title
    Fatigue Scale: Cy4D1 (n=176, 86)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.14
        value
        47.7
      2. group Id
        OG001
        spread
        33.53
        value
        50.8
    title
    Future Health: Baseline (n=206, 101)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.74
        value
        29.5
      2. group Id
        OG001
        spread
        30.33
        value
        39.1
    title
    Future Health: Cy4D1 (n=175, 86)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.91
        value
        12
      2. group Id
        OG001
        spread
        17.97
        value
        14.6
    title
    Infection Scale: Baseline (n=209, 102)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.65
        value
        8.9
      2. group Id
        OG001
        spread
        10.70
        value
        8.5
    title
    Infection Scale: Cy4D1 (n=176, 86)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.99
        value
        24.3
      2. group Id
        OG001
        spread
        33.26
        value
        26.3
    title
    Social Problems: Baseline (n=206, 100)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.75
        value
        19.4
      2. group Id
        OG001
        spread
        27.00
        value
        22.0
    title
    Social Problems: Cy4D1 (n=175, 85)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.7
        value
        19.8
      2. group Id
        OG001
        spread
        15.27
        value
        17.2
    title
    Treatment Side Effects Scale: Baseline (n=209,102)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.68
        value
        14.7
      2. group Id
        OG001
        spread
        16.11
        value
        15.6
    title
    Treatment Side Effect Scale: Cy4D1(n=176,86)
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      118
    units
    Participants
description
EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    OG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    OG001
    title
    Chlorambucil (Clb)
param Type
MEAN
population Description
ITT population. Here, n signifies the number of participants who were evaluated for specified categories.
reporting Status
POSTED
time Frame
Baseline and Cycle 4 Day 1 (Cy4D1)
title
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
type
SECONDARY
unit Of Measure
unit on a scale

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

Preserved source evidence · Not medical advice