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NCT02005471 · OUTCOME

Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) · Source last updated 2023-10-17

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

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

What was measured

The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL.

Analysis population: PRO evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.

Groups in this outcome

Bendamustine + Rituximab Main Study

Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

Venetoclax + Rituximab Main Study

Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

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
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	69

Reported measurements

Baseline; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	69

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	14.29	13.95	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	9.42	8.80	Not reported	Not reported	Not reported

Change at C1D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.0	0.0	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.12	10.10	Not reported	Not reported	Not reported

Change at C2D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	170
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	1.62	13.82	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.62	12.76	Not reported	Not reported	Not reported

Change at C3D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	159
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.26	13.76	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	1.98	14.72	Not reported	Not reported	Not reported

Change at C4D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	152
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.49	13.97	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.52	11.87	Not reported	Not reported	Not reported

Change at C5D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	147
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.51	14.57	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.64	10.02	Not reported	Not reported	Not reported

Change at C6D1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	144
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.46	15.51	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-0.13	10.04	Not reported	Not reported	Not reported

Change at STC/EW; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	161
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.81	18.11	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.13	10.76	Not reported	Not reported	Not reported

Change at EoCTR; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	142
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.88	16.06	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.26	12.61	Not reported	Not reported	Not reported

Change at FUV1; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	123
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.20	14.87	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	1.19	12.24	Not reported	Not reported	Not reported

Change at FUV2; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	113
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.70	15.28	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	2.65	14.03	Not reported	Not reported	Not reported

Change at FUV3; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	95
Venetoclax + Rituximab Main Study	62

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.08	12.64	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-0.13	13.70	Not reported	Not reported	Not reported

Change at FUV4; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	76
Venetoclax + Rituximab Main Study	47

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.97	12.76	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	2.84	15.18	Not reported	Not reported	Not reported

Change at FUV5; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	56
Venetoclax + Rituximab Main Study	19

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.68	11.02	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	1.32	10.49	Not reported	Not reported	Not reported

Change at FUV6; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	33
Venetoclax + Rituximab Main Study	5

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.01	12.10	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-1.67	3.73	Not reported	Not reported	Not reported

Change at FUV7; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	13
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	2.56	22.67	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-8.33	Not reported	Not reported	Not reported	Not reported

Change at FUV8; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	5
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	1.67	13.69	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.00	Not reported	Not reported	Not reported	Not reported

Change at FUV9; TRSE

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	2
Venetoclax + Rituximab Main Study	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	8.33	11.79	Not reported	Not reported	Not reported

Baseline; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	69

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	19.57	16.81	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	16.95	17.37	Not reported	Not reported	Not reported

Change at C1D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.0	0.0	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.74	16.18	Not reported	Not reported	Not reported

Change at C2D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	170
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-3.33	16.05	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.77	16.84	Not reported	Not reported	Not reported

Change at C3D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	159
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-4.77	16.49	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.35	17.48	Not reported	Not reported	Not reported

Change at C4D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	152
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.03	16.51	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-5.12	17.72	Not reported	Not reported	Not reported

Change at C5D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	147
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-5.90	16.73	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.79	17.50	Not reported	Not reported	Not reported

Change at C6D1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	144
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.40	17.26	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-5.30	16.72	Not reported	Not reported	Not reported

Change at STC/EW; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	161
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-5.80	18.52	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-6.51	18.45	Not reported	Not reported	Not reported

Change at EoCTR; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	142
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.57	17.21	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-5.86	20.38	Not reported	Not reported	Not reported

Change at FUV1; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	123
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.55	15.73	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-5.82	19.20	Not reported	Not reported	Not reported

Change at FUV2; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	113
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-8.63	14.39	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.57	18.31	Not reported	Not reported	Not reported

Change at FUV3; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	95
Venetoclax + Rituximab Main Study	62

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-7.37	14.88	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.76	19.25	Not reported	Not reported	Not reported

Change at FUV4; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	76
Venetoclax + Rituximab Main Study	47

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-8.55	18.56	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.66	20.49	Not reported	Not reported	Not reported

Change at FUV5; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	56
Venetoclax + Rituximab Main Study	19

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-8.33	16.13	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.19	19.41	Not reported	Not reported	Not reported

Change at FUV6; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	33
Venetoclax + Rituximab Main Study	5

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.31	16.01	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.33	13.94	Not reported	Not reported	Not reported

Change at FUV7; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	13
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-15.38	20.08	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-8.33	Not reported	Not reported	Not reported	Not reported

Change at FUV8; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	5
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-10.00	16.03	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-8.33	Not reported	Not reported	Not reported	Not reported

Change at FUV9; DRS

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	2
Venetoclax + Rituximab Main Study	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-4.17	5.89	Not reported	Not reported	Not reported

Baseline; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	69

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	28.76	24.66	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	21.74	20.67	Not reported	Not reported	Not reported

Change at C1D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.0	0.0	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.24	20.29	Not reported	Not reported	Not reported

Change at C2D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	170
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.55	22.86	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-5.47	21.40	Not reported	Not reported	Not reported

Change at C3D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	159
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.83	25.17	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.17	23.73	Not reported	Not reported	Not reported

Change at C4D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	152
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-3.18	23.23	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.17	22.02	Not reported	Not reported	Not reported

Change at C5D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	147
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.38	27.52	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.36	20.89	Not reported	Not reported	Not reported

Change at C6D1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	144
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.66	26.35	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.31	21.42	Not reported	Not reported	Not reported

Change at STC/EW; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	161
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-3.11	28.64	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.69	21.30	Not reported	Not reported	Not reported

Change at EoCTR; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	142
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.69	26.78	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.97	24.27	Not reported	Not reported	Not reported

Change at FUV1; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	123
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.37	26.61	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-4.23	22.99	Not reported	Not reported	Not reported

Change at FUV2; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	113
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.64	24.55	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-1.85	24.70	Not reported	Not reported	Not reported

Change at FUV3; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	95
Venetoclax + Rituximab Main Study	62

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-5.79	23.29	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.42	23.73	Not reported	Not reported	Not reported

Change at FUV4; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	76
Venetoclax + Rituximab Main Study	47

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-9.65	26.84	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-0.35	25.18	Not reported	Not reported	Not reported

Change at FUV5; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	56
Venetoclax + Rituximab Main Study	19

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.55	25.56	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	3.51	23.95	Not reported	Not reported	Not reported

Change at FUV6; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	33
Venetoclax + Rituximab Main Study	5

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-5.05	24.82	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	3.33	24.72	Not reported	Not reported	Not reported

Change at FUV7; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	13
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-10.26	30.08	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-33.33	Not reported	Not reported	Not reported	Not reported

Change at FUV8; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	5
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-6.67	19.00	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.00	Not reported	Not reported	Not reported	Not reported

Change at FUV9; Fatigue

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	2
Venetoclax + Rituximab Main Study	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-8.33	11.79	Not reported	Not reported	Not reported

Baseline; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	69

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	15.92	17.63	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	14.01	18.99	Not reported	Not reported	Not reported

Change at C1D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	175
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.0	0.0	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.24	20.03	Not reported	Not reported	Not reported

Change at C2D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	170
Venetoclax + Rituximab Main Study	67

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.02	19.98	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.61	21.72	Not reported	Not reported	Not reported

Change at C3D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	159
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.66	19.21	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-1.32	20.48	Not reported	Not reported	Not reported

Change at C4D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	152
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.44	22.07	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.13	21.28	Not reported	Not reported	Not reported

Change at C5D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	147
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.91	24.00	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.56	23.47	Not reported	Not reported	Not reported

Change at C6D1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	143
Venetoclax + Rituximab Main Study	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.09	20.66	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.95	20.54	Not reported	Not reported	Not reported

Change at STC/EW; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	161
Venetoclax + Rituximab Main Study	64

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.12	23.28	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-1.69	23.34	Not reported	Not reported	Not reported

Change at EoCTR; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	142
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.55	21.73	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-3.44	25.78	Not reported	Not reported	Not reported

Change at FUV1; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	121
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	1.08	18.77	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-2.65	26.51	Not reported	Not reported	Not reported

Change at FUV2; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	113
Venetoclax + Rituximab Main Study	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	0.05	23.29	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-0.53	25.74	Not reported	Not reported	Not reported

Change at FUV3; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	95
Venetoclax + Rituximab Main Study	62

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.90	16.97	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-0.54	26.48	Not reported	Not reported	Not reported

Change at FUV4; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	76
Venetoclax + Rituximab Main Study	47

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-4.24	16.71	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	0.53	25.56	Not reported	Not reported	Not reported

Change at FUV5; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	56
Venetoclax + Rituximab Main Study	19

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-4.51	22.66	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	7.46	27.20	Not reported	Not reported	Not reported

Change at FUV6; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	33
Venetoclax + Rituximab Main Study	5

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-1.60	18.90	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	8.33	15.59	Not reported	Not reported	Not reported

Change at FUV7; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	13
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-0.43	21.84	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-16.67	Not reported	Not reported	Not reported	Not reported

Change at FUV8; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	5
Venetoclax + Rituximab Main Study	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	8.89	23.36	Not reported	Not reported	Not reported
Venetoclax + Rituximab Main Study	-25.00	Not reported	Not reported	Not reported	Not reported

Change at FUV9; Infection

Analysis denominator · Participants

Group	Source count
Bendamustine + Rituximab Main Study	2
Venetoclax + Rituximab Main Study	0

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine + Rituximab Main Study	-2.78	3.93	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
13.95
value
14.29
group Id
OG001
spread
8.80
value
9.42
denoms
counts
group Id
OG000
value
175
group Id
OG001
value
69
units
Participants
title
Baseline; TRSE
categories
measurements
group Id
OG000
spread
0.0
value
0.0
group Id
OG001
spread
10.10
value
0.12
denoms
counts
group Id
OG000
value
175
group Id
OG001
value
67
units
Participants
title
Change at C1D1; TRSE
categories
measurements
group Id
OG000
spread
13.82
value
1.62
group Id
OG001
spread
12.76
value
0.62
denoms
counts
group Id
OG000
value
170
group Id
OG001
value
67
units
Participants
title
Change at C2D1; TRSE
categories
measurements
group Id
OG000
spread
13.76
value
-0.26
group Id
OG001
spread
14.72
value
1.98
denoms
counts
group Id
OG000
value
159
group Id
OG001
value
63
units
Participants
title
Change at C3D1; TRSE
categories
measurements
group Id
OG000
spread
13.97
value
-0.49
group Id
OG001
spread
11.87
value
0.52
denoms
counts
group Id
OG000
value
152
group Id
OG001
value
64
units
Participants
title
Change at C4D1; TRSE
categories
measurements
group Id
OG000
spread
14.57
value
-0.51
group Id
OG001
spread
10.02
value
0.64
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
65
units
Participants
title
Change at C5D1; TRSE
categories
measurements
group Id
OG000
spread
15.51
value
0.46
group Id
OG001
spread
10.04
value
-0.13
denoms
counts
group Id
OG000
value
144
group Id
OG001
value
65
units
Participants
title
Change at C6D1; TRSE
categories
measurements
group Id
OG000
spread
18.11
value
0.81
group Id
OG001
spread
10.76
value
0.13
denoms
counts
group Id
OG000
value
161
group Id
OG001
value
64
units
Participants
title
Change at STC/EW; TRSE
categories
measurements
group Id
OG000
spread
16.06
value
-0.88
group Id
OG001
spread
12.61
value
0.26
denoms
counts
group Id
OG000
value
142
group Id
OG001
value
63
units
Participants
title
Change at EoCTR; TRSE
categories
measurements
group Id
OG000
spread
14.87
value
-1.20
group Id
OG001
spread
12.24
value
1.19
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
63
units
Participants
title
Change at FUV1; TRSE
categories
measurements
group Id
OG000
spread
15.28
value
-1.70
group Id
OG001
spread
14.03
value
2.65
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
63
units
Participants
title
Change at FUV2; TRSE
categories
measurements
group Id
OG000
spread
12.64
value
-2.08
group Id
OG001
spread
13.70
value
-0.13
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
62
units
Participants
title
Change at FUV3; TRSE

denoms

counts
group Id
OG000
value
175
group Id
OG001
value
69
units
Participants

description

The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL.

dispersion Type

Standard Deviation

groups

description
Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
id
OG000
title
Bendamustine + Rituximab Main Study
description
Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
id
OG001
title
Venetoclax + Rituximab Main Study

param Type

MEAN

population Description

PRO evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.

reporting Status

POSTED

time Frame

Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

title

Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice