European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 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
The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. 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
Group
Source count
Obinutuzumab + Chlorambucil (GClb)
238
Chlorambucil (Clb)
118
Reported measurements
Appetite Loss Scale: Baseline (n=226, 111)
Values in unit on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Obinutuzumab + Chlorambucil (GClb)
18.1
28.46
Not reported
Not reported
Not reported
Chlorambucil (Clb)
19.8
29.26
Not reported
Not reported
Not reported
Appetite Loss Scale: Cy4D1 (n=189, 92)
Values in unit on a scale · Interval/dispersion: Standard Deviation
The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. 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
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)
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-C30 Questionnaire Score
Triangle