Health-related quality of life and patient-reported outcomes of ofatumumab plus chlorambucil versus chlorambucil monotherapy in the COMPLEMENT 1 trial of patients with previously untreated CLL

Figures & data

Figure 1. Patients completing questionnaires on treatment (Global Health Status/Health-Related Quality of Life).

Figure 2. Change from baseline in Global Health Status of the EORTC QLQ-C30 for patients during the treatment period. Positive change indicates improved HRQoL.

Figure 3. Change from baseline in fatigue score of the EORTC QLQ-CLL16 for patients during the treatment period. Negative change indicates improvement in symptoms.

Table 1. ANCOVA for change from baseline in GHS/HRQoL and B symptoms at Cycle 4 for patients during the treatment period, regardless of treatment arm.

GHS/HRQoL	n	Mean change	SE	Difference in mean change	p-Value
Responder	265	3.18	2.01	−0.11	0.973
Non-responder	33	3.29	3.66
Fatigue
Responder	275	−7.09	2.31	−3.19	0.404
Non-responder	33	−3.90	4.23
B-symptom score
Responder	283	−8.29	1.39	−0.36	0.877
Non-responder	33	−7.93	2.55

ANCOVA: analysis of covariance; GHS: Global Health Status; HRQoL: health-related quality of life; SE: standard error.

Table 2. MMRM analysis for the change from baseline in B-symptom score, EORTC QLQ-CLL16 infection score, and EORTC QLQ-C30 emotional functioning for patients during the treatment period.

B-symptom score	n	Mean change	SE	Difference in mean change	p-Value
CHL	213	−8.66	1.64	3.98	0.035
O + CHL	232	−12.64	1.75
EORTC QLQ-CLL16 infection score
CHL	209	−4.46	1.68	5.37	0.003
O + CHL	226	−9.83	1.69
EORTC QLQ-C30 emotional functioning
CHL	212	2.43	2.22	−7.53	0.005
O + CHL	230	9.95	2.32

CHL: chlorambucil; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-CLL16: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia 16-item module; MMRM: mixed-model repeated measures; O + CHL: ofatumumab combined with chlorambucil; SE: standard error.

Figure 4. Patients completing questionnaires post-treatment (GHS/HRQoL).

Figure 5. Change from baseline (last on-treatment score) in Global Health Status of the EORTC QLQ-C30 for patients during post-treatment follow-up. Positive change indicates improved HRQoL.

Figure 6. Change from baseline (last on-treatment score) in fatigue score of the EORTC QLQ-CLL16 for patients during post-treatment follow-up. Negative change indicates improvement in symptoms.