Trial Outcomes & Findings for A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (NCT NCT02320487)

NCT ID: NCT02320487

Last Updated: 2020-02-11

Results Overview

The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes \< 4 times 10\^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L, and hemoglobin \> 11.0 g/dL; normocellular BM aspirate with \< 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Obinutuzumab + Bendamustine (BG) Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Overall Study STARTED	102
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Obinutuzumab + Bendamustine (BG) Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Overall Study Reason not Specified	1
Overall Study Physician Decision	5
Overall Study Withdrawal by Subject	1
Overall Study Death	3
Overall Study Adverse Event	11

Baseline Characteristics

A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Age, Continuous	62.5 years STANDARD_DEVIATION 10.79 • n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	70 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	98 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)

Population: The modified intent-to-treat (mITT) population included enrolled participants who received at least one dose of BG.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines	50.0 percentage of participants Interval 39.9 to 60.1

SECONDARY outcome

Timeframe: 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)

Population: The mITT population included enrolled participants who received at least one dose of BG.

CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: \>/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; \>/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L or \>/= 50% improvement from Baseline, or hemoglobin \> 11.0 g/dL or \>/= 50% improvement from Baseline.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines	89.2 percentage of participants Interval 81.5 to 94.5

SECONDARY outcome

Timeframe: From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)

Population: The mITT population included enrolled participants who received at least one dose of BG. Analysis performed for participants with response.

Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=91 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines	NA months Not estimable due to the low number participants with events that qualified for the analysis.

SECONDARY outcome

Timeframe: Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)

Population: The mITT population included enrolled participants who received at least one dose of BG.

PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines	NA months Interval 35.0 to Not estimable due to the low number participants with events that qualified for the analysis.

SECONDARY outcome

Timeframe: Day 1 until death from any cause (up to 46 months)

Population: The mITT population included enrolled participants who received at least one dose of BG.

OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Overall Survival (OS)	NA months Not estimable due to the low number participants with events that qualified for the analysis.

SECONDARY outcome

Timeframe: Up to 46 months

Population: The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.

MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (\<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=51 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow at Any Time During the Study	58.8 percentage of participants Interval 44.2 to 72.4

SECONDARY outcome

Timeframe: Baseline up to 46 months

Population: The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=95 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood at Any Time During the Study	83.2 percentage of participants Interval 74.1 to 90.1

SECONDARY outcome

Timeframe: Baseline up to 46 months

Population: The mITT population included enrolled participants who received at least one dose of BG.

MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity if the value is \<10\^-4 (\<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Time to MRD-negative status is defined as the time between MRD positivity (\>= 10\^-4) or the time of first dose treatment for patients who were missing MRD status assessment at baseline to the first achievement of MRD negativity in the peripheral blood.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Time to MRD-Negative Status in Peripheral Blood	8.2 months Interval 7.1 to 10.3

SECONDARY outcome

Timeframe: Baseline up to 46 months

Population: The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.

MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (\<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Duration of MRD-negativity among patients who achieved MRD negativity in the study is defined as the period between the first occurrence of MRD-negative status and a subsequent MRD-positive status.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=79 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status	28.9 months Interval 23.0 to Not estimable due to the low number of participants with events that qualified for the analysis.

SECONDARY outcome

Timeframe: Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days)

Population: The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.

Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=95 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2	235.92 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.01

SECONDARY outcome

Timeframe: Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days)

Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=80 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Ctrough of Obinutuzumab After Cycle 4	264.27 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 46.45

SECONDARY outcome

Timeframe: Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days)

Population: The PRO (patient-reported outcome) Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.

The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, 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 a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=98 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: EOT/Early Discontinuation	-3.80 score on a scale Standard Deviation 18.480
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Response Visit	-7.06 score on a scale Standard Deviation 21.878
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 3-Month Follow-Up	-9.91 score on a scale Standard Deviation 18.896
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 6-Month Follow-Up	-9.60 score on a scale Standard Deviation 18.270
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 9-Month Follow-Up	-10.80 score on a scale Standard Deviation 22.378
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 12-Month Follow-Up	-8.75 score on a scale Standard Deviation 20.364
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 15-Month Follow-Up	-6.57 score on a scale Standard Deviation 24.312
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 18-Month Follow-Up	-7.41 score on a scale Standard Deviation 19.557
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 21-Month Follow-Up	-4.90 score on a scale Standard Deviation 23.928
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 24-Month Follow-Up	-7.47 score on a scale Standard Deviation 20.748
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 27-Month Follow-Up	-8.16 score on a scale Standard Deviation 19.872
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: 30-Month Follow-Up	-6.67 score on a scale Standard Deviation 14.906
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: Cycle 3	3.92 score on a scale Standard Deviation 34.661
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: Cycle 6	-0.00 score on a scale Standard Deviation 24.944
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: EOT/Early Discontinuation	-4.27 score on a scale Standard Deviation 18.105
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: Response Visit	-4.36 score on a scale Standard Deviation 24.147
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 3-Month Follow-Up	-5.02 score on a scale Standard Deviation 18.979
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 6-Month Follow-Up	-6.06 score on a scale Standard Deviation 19.312
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 9-Month Follow-Up	-5.16 score on a scale Standard Deviation 24.975
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 12-Month Follow-Up	-3.80 score on a scale Standard Deviation 25.028
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 15-Month Follow-Up	-3.76 score on a scale Standard Deviation 19.147
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 18-Month Follow-Up	-0.46 score on a scale Standard Deviation 24.059
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 21-Month Follow-Up	-2.45 score on a scale Standard Deviation 22.538
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 24-Month Follow-Up	-6.32 score on a scale Standard Deviation 21.134
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 27-Month Follow-Up	-6.80 score on a scale Standard Deviation 21.494
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation: 30-Month Follow-Up	0.00 score on a scale Standard Deviation 0.000
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: Cycle 3	1.18 score on a scale Standard Deviation 21.483
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: Cycle 6	4.82 score on a scale Standard Deviation 24.767
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: EOT/Early Discontinuation	4.64 score on a scale Standard Deviation 29.105
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: Response Visit	2.75 score on a scale Standard Deviation 24.780
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 3-Month Follow-Up	-2.25 score on a scale Standard Deviation 20.886
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 6-Month Follow-Up	-1.01 score on a scale Standard Deviation 24.085
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 9-Month Follow-Up	3.24 score on a scale Standard Deviation 23.174
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 12-Month Follow-Up	-0.43 score on a scale Standard Deviation 21.816
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 15-Month Follow-Up	0.00 score on a scale Standard Deviation 25.197
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 18-Month Follow-Up	-2.78 score on a scale Standard Deviation 26.090
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 21-Month Follow-Up	3.43 score on a scale Standard Deviation 28.875
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 24-Month Follow-Up	-0.57 score on a scale Standard Deviation 22.067
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 27-Month Follow-Up	1.36 score on a scale Standard Deviation 21.471
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhoea: 30-Month Follow-Up	0.00 score on a scale Standard Deviation 23.568
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: Cycle 3	0.78 score on a scale Standard Deviation 25.186
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: Cycle 6	-2.19 score on a scale Standard Deviation 27.934
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: EOT/Early Discont.	-1.27 score on a scale Standard Deviation 26.923
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: Response Visit	-3.53 score on a scale Standard Deviation 29.107
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 3-Month Follow-Up	-5.86 score on a scale Standard Deviation 27.784
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 6-Month Follow-Up	-7.18 score on a scale Standard Deviation 27.947
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 9-Month Follow-Up	-7.04 score on a scale Standard Deviation 26.972
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 12-Month Follow-Up	-3.80 score on a scale Standard Deviation 30.188
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 15-Month Follow-Up	-8.45 score on a scale Standard Deviation 29.125
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 18-Month Follow-Up	-6.02 score on a scale Standard Deviation 31.313
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 21-Month Follow-Up	-6.86 score on a scale Standard Deviation 25.471
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 24-Month Follow-Up	-7.47 score on a scale Standard Deviation 26.523
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 27-Month Follow-Up	-11.56 score on a scale Standard Deviation 31.587
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulty: 30-Month Follow-Up	-13.33 score on a scale Standard Deviation 29.813
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status (GHS)/QoL: Cycle 3	4.02 score on a scale Standard Deviation 21.540
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: Cycle 6	5.26 score on a scale Standard Deviation 22.478
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: EOT/Early Discontinuation	5.17 score on a scale Standard Deviation 26.731
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: Response Visit	10.98 score on a scale Standard Deviation 21.715
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 3-Month Follow-Up	10.25 score on a scale Standard Deviation 24.733
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 6-Month Follow-Up	5.68 score on a scale Standard Deviation 30.140
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 9-Month Follow-Up	9.26 score on a scale Standard Deviation 23.384
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 12-Month Follow-Up	6.43 score on a scale Standard Deviation 24.676
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 15-Month Follow-Up	6.57 score on a scale Standard Deviation 25.969
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 18-Month Follow-Up	9.84 score on a scale Standard Deviation 26.732
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 21-Month Follow-Up	7.60 score on a scale Standard Deviation 27.117
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 24-Month Follow-Up	8.91 score on a scale Standard Deviation 27.388
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 27-Month Follow-Up	13.26 score on a scale Standard Deviation 24.468
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score GHS/QoL: 30-Month Follow-Up	1.66 score on a scale Standard Deviation 28.501
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: Cycle 3	-2.46 score on a scale Standard Deviation 14.948
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: Cycle 6	0.00 score on a scale Standard Deviation 12.842
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Phys. Function: EOT/Early Discontinuation	2.62 score on a scale Standard Deviation 15.188
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: Response Visit	3.90 score on a scale Standard Deviation 14.705
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 3-Month Follow-Up	4.14 score on a scale Standard Deviation 13.769
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 6-Month Follow-Up	1.62 score on a scale Standard Deviation 17.308
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 9-Month Follow-Up	4.95 score on a scale Standard Deviation 15.208
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 12-Month Follow-Up	3.00 score on a scale Standard Deviation 15.221
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 15-Month Follow-Up	2.44 score on a scale Standard Deviation 17.647
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 18-Month Follow-Up	1.11 score on a scale Standard Deviation 18.589
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 21-Month Follow-Up	1.37 score on a scale Standard Deviation 13.509
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 24-Month Follow-Up	3.10 score on a scale Standard Deviation 14.467
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 27-Month Follow-Up	4.22 score on a scale Standard Deviation 14.057
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Function: 30-Month Follow-Up	5.34 score on a scale Standard Deviation 8.691
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: Cycle 3	6.01 score on a scale Standard Deviation 24.775
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: Cycle 6	4.11 score on a scale Standard Deviation 27.193
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: EOT/Early Discontinuation	10.55 score on a scale Standard Deviation 27.108
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: Response Visit	13.14 score on a scale Standard Deviation 29.106
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 3-Month Follow-Up	14.87 score on a scale Standard Deviation 28.210
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 6-Month Follow-Up	10.86 score on a scale Standard Deviation 29.453
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 9-Month Follow-Up	15.51 score on a scale Standard Deviation 27.312
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 12-Month Follow-Up	10.63 score on a scale Standard Deviation 28.591
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 15-Month Follow-Up	12.68 score on a scale Standard Deviation 30.920
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 18-Month Follow-Up	10.88 score on a scale Standard Deviation 33.352
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 21-Month Follow-Up	10.95 score on a scale Standard Deviation 28.656
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 24-Month Follow-Up	11.49 score on a scale Standard Deviation 30.780
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 27-Month Follow-Up	14.97 score on a scale Standard Deviation 30.285
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Function: 30-Month Follow-Up	-13.33 score on a scale Standard Deviation 36.132
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: Cycle 3	7.91 score on a scale Standard Deviation 18.092
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: Cycle 6	6.29 score on a scale Standard Deviation 18.304
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: EOT/Early Discont.	9.60 score on a scale Standard Deviation 18.302
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: Response Visit	9.12 score on a scale Standard Deviation 18.663
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 3-Month Follow-Up	8.11 score on a scale Standard Deviation 18.861
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 6-Month Follow-Up	6.94 score on a scale Standard Deviation 19.424
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 9-Month Follow-Up	11.00 score on a scale Standard Deviation 13.402
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 12-Month Follow-Up	7.81 score on a scale Standard Deviation 18.793
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 15-Month Follow-Up	6.34 score on a scale Standard Deviation 23.883
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 18-Month Follow-Up	5.75 score on a scale Standard Deviation 22.214
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 21-Month Follow-Up	7.11 score on a scale Standard Deviation 19.597
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 24-Month Follow-Up	9.77 score on a scale Standard Deviation 19.380
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 27-Month Follow-Up	10.15 score on a scale Standard Deviation 18.845
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Function: 30-Month Follow-Up	8.33 score on a scale Standard Deviation 15.591
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: Cycle 3	2.55 score on a scale Standard Deviation 22.640
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: Cycle 6	-1.75 score on a scale Standard Deviation 25.177
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: EOT/Early Discont.	0.42 score on a scale Standard Deviation 17.697
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: Response Visit	2.74 score on a scale Standard Deviation 20.387
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 3-Month Follow-Up	2.25 score on a scale Standard Deviation 17.946
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 6-Month Follow-Up	1.77 score on a scale Standard Deviation 23.043
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 9-Month Follow-Up	6.02 score on a scale Standard Deviation 17.312
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 12-Month Follow-Up	1.48 score on a scale Standard Deviation 19.646
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 15-Month Follow-Up	2.11 score on a scale Standard Deviation 20.878
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 18-Month Follow-Up	2.55 score on a scale Standard Deviation 20.105
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 21-Month Follow-Up	3.19 score on a scale Standard Deviation 20.815
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 24-Month Follow-Up	4.02 score on a scale Standard Deviation 18.550
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 27-Month Follow-Up	1.70 score on a scale Standard Deviation 16.401
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Function: 30-Month Follow-Up	-3.33 score on a scale Standard Deviation 21.726
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: Cycle 3	-2.35 score on a scale Standard Deviation 21.386
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: Cycle 6	-4.17 score on a scale Standard Deviation 23.590
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: EOT/Early Discontinuation	2.53 score on a scale Standard Deviation 23.279
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: Response Visit	5.69 score on a scale Standard Deviation 24.874
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 3-Month Follow-Up	5.41 score on a scale Standard Deviation 23.587
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 6-Month Follow-Up	-0.25 score on a scale Standard Deviation 26.872
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 9-Month Follow-Up	8.10 score on a scale Standard Deviation 19.579
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 12-Month Follow-Up	2.74 score on a scale Standard Deviation 24.667
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 15-Month Follow-Up	3.76 score on a scale Standard Deviation 25.696
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 18-Month Follow-Up	3.70 score on a scale Standard Deviation 27.296
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 21-Month Follow-Up	2.70 score on a scale Standard Deviation 26.952
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 24-Month Follow-Up	5.46 score on a scale Standard Deviation 21.032
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 27-Month Follow-Up	7.48 score on a scale Standard Deviation 23.088
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Function: 30-Month Follow-Up	-10.00 score on a scale Standard Deviation 30.277
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: Cycle 3	-4.01 score on a scale Standard Deviation 25.433
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: Cycle 6	-5.48 score on a scale Standard Deviation 24.558
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: EOT/Early Discontinuation	-11.67 score on a scale Standard Deviation 24.324
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: Response Visit	-16.34 score on a scale Standard Deviation 25.291
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 3-Month Follow-Up	-15.92 score on a scale Standard Deviation 24.266
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 6-Month Follow-Up	-13.64 score on a scale Standard Deviation 24.171
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 9-Month Follow-Up	-17.28 score on a scale Standard Deviation 23.947
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 12-Month Follow-Up	-13.12 score on a scale Standard Deviation 24.261
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 15-Month Follow-Up	-11.27 score on a scale Standard Deviation 25.441
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 18-Month Follow-Up	-13.43 score on a scale Standard Deviation 24.946
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 21-Month Follow-Up	-13.07 score on a scale Standard Deviation 22.465
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 24-Month Follow-Up	-14.37 score on a scale Standard Deviation 21.429
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 27-Month Follow-Up	-14.51 score on a scale Standard Deviation 23.373
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue: 30-Month Follow-Up	-2.22 score on a scale Standard Deviation 16.480
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: Cycle 3	2.33 score on a scale Standard Deviation 16.990
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: Cycle 6	3.68 score on a scale Standard Deviation 14.210
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: EOT/Early Discontinuation	2.32 score on a scale Standard Deviation 13.273
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: Response Visit	-0.39 score on a scale Standard Deviation 15.209
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 3-Month Follow-Up	-1.58 score on a scale Standard Deviation 9.624
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 6-Month Follow-Up	-1.26 score on a scale Standard Deviation 12.164
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 9-Month Follow-Up	-0.23 score on a scale Standard Deviation 16.428
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 12-Month Follow-Up	-1.04 score on a scale Standard Deviation 13.350
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 15-Month Follow-Up	0.70 score on a scale Standard Deviation 13.926
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 18-Month Follow-Up	-0.23 score on a scale Standard Deviation 13.267
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 21-Month Follow-Up	-1.72 score on a scale Standard Deviation 13.240
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 24-Month Follow-Up	-2.01 score on a scale Standard Deviation 14.333
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 27-Month Follow-Up	-1.70 score on a scale Standard Deviation 14.925
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea/Vomiting: 30-Month Follow-Up	10.00 score on a scale Standard Deviation 14.910
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: Cycle 3	-3.68 score on a scale Standard Deviation 17.969
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: Cycle 6	0.65 score on a scale Standard Deviation 26.826
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: EOT/Early Discontinuation	-1.90 score on a scale Standard Deviation 21.012
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: Response Visit	-4.90 score on a scale Standard Deviation 20.865
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 3-Month Follow-Up	-1.80 score on a scale Standard Deviation 17.570
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 6-Month Follow-Up	-1.52 score on a scale Standard Deviation 20.615
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 9-Month Follow-Up	-0.69 score on a scale Standard Deviation 20.448
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 12-Month Follow-Up	-0.21 score on a scale Standard Deviation 24.947
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 15-Month Follow-Up	0.94 score on a scale Standard Deviation 26.709
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 18-Month Follow-Up	-0.46 score on a scale Standard Deviation 25.326
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 21-Month Follow-Up	-0.00 score on a scale Standard Deviation 23.035
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 24-Month Follow-Up	-2.59 score on a scale Standard Deviation 19.447
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 27-Month Follow-Up	-5.44 score on a scale Standard Deviation 26.654
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain: 30-Month Follow-Up	6.67 score on a scale Standard Deviation 48.015
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: Cycle 3	0.39 score on a scale Standard Deviation 27.294
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: Cycle 6	-1.73 score on a scale Standard Deviation 25.874
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: EOT/Early Discontinuation	-5.91 score on a scale Standard Deviation 31.013
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: Response Visit	-5.88 score on a scale Standard Deviation 30.069
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 3-Month Follow-Up	-9.46 score on a scale Standard Deviation 27.872
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 6-Month Follow-Up	-8.08 score on a scale Standard Deviation 27.463
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 9-Month Follow-Up	-7.87 score on a scale Standard Deviation 29.334
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 12-Month Follow-Up	-5.83 score on a scale Standard Deviation 30.824
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 15-Month Follow-Up	-5.63 score on a scale Standard Deviation 29.270
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 18-Month Follow-Up	-7.87 score on a scale Standard Deviation 28.796
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 21-Month Follow-Up	-8.82 score on a scale Standard Deviation 27.289
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 24-Month Follow-Up	-7.47 score on a scale Standard Deviation 28.642
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 27-Month Follow-Up	-11.56 score on a scale Standard Deviation 31.587
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea: 30-Month Follow-Up	-20.00 score on a scale Standard Deviation 18.256
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: Cycle 3	-6.59 score on a scale Standard Deviation 27.450
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: Cycle 6	-9.09 score on a scale Standard Deviation 24.565
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: EOT/Early Discontinuation	-9.70 score on a scale Standard Deviation 25.684
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: Response Visit	-10.98 score on a scale Standard Deviation 28.354
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 3-Month Follow-Up	-9.46 score on a scale Standard Deviation 25.596
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 6-Month Follow-Up	-14.65 score on a scale Standard Deviation 29.312
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 9-Month Follow-Up	-12.50 score on a scale Standard Deviation 29.306
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 12-Month Follow-Up	-9.70 score on a scale Standard Deviation 31.193
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 15-Month Follow-Up	-13.61 score on a scale Standard Deviation 30.643
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 18-Month Follow-Up	-8.80 score on a scale Standard Deviation 30.640
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 21-Month Follow-Up	-7.84 score on a scale Standard Deviation 29.991
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 24-Month Follow-Up	-14.37 score on a scale Standard Deviation 28.691
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 27-Month Follow-Up	-10.20 score on a scale Standard Deviation 36.136
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia: 30-Month Follow-Up	-6.67 score on a scale Standard Deviation 49.443
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Cycle 3	-2.71 score on a scale Standard Deviation 20.589
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Cycle 6	0.00 score on a scale Standard Deviation 26.490

SECONDARY outcome

Timeframe: Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days)

Population: The PRO Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.

The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, 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 a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=98 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: Cycle 3	-12.02 score on a scale Standard Deviation 26.892
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: Cycle 6	-10.17 score on a scale Standard Deviation 26.373
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: EOT/Early Discontinuation	-12.87 score on a scale Standard Deviation 30.306
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: Response Visit	-21.23 score on a scale Standard Deviation 30.759
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 3-Month Follow-Up	-20.04 score on a scale Standard Deviation 29.323
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 6-Month Follow-Up	-17.44 score on a scale Standard Deviation 25.418
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 9-Month Follow-Up	-22.77 score on a scale Standard Deviation 27.780
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 12-Month Follow-Up	-17.32 score on a scale Standard Deviation 25.569
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 15-Month Follow-Up	-14.52 score on a scale Standard Deviation 30.153
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 18-Month Follow-Up	-15.49 score on a scale Standard Deviation 30.122
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 21-Month Follow-Up	-16.42 score on a scale Standard Deviation 28.646
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 24-Month Follow-Up	-24.70 score on a scale Standard Deviation 25.621
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 27-Month Follow-Up	-19.56 score on a scale Standard Deviation 26.597
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Fatigue: 30-Month Follow-Up	-6.67 score on a scale Standard Deviation 53.489
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: Cycle 3	1.52 score on a scale Standard Deviation 12.019
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: Cycle 6	0.07 score on a scale Standard Deviation 16.072
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: EOT/Early Discontinuation	-0.67 score on a scale Standard Deviation 16.357
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: Response Visit	-2.08 score on a scale Standard Deviation 14.520
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 3-Month Follow-Up	-3.30 score on a scale Standard Deviation 12.904
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 6-Month Follow-Up	-2.61 score on a scale Standard Deviation 15.182
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 9-Month Follow-Up	-3.36 score on a scale Standard Deviation 14.548
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 12-Month Follow-Up	-2.27 score on a scale Standard Deviation 14.841
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 15-Month Follow-Up	-3.17 score on a scale Standard Deviation 14.355
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 18-Month Follow-Up	-4.54 score on a scale Standard Deviation 14.813
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 21-Month Follow-Up	-1.66 score on a scale Standard Deviation 16.277
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 24-Month Follow-Up	-3.08 score on a scale Standard Deviation 13.699
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 27-Month Follow-Up	-2.96 score on a scale Standard Deviation 14.434
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Side Effects: 30-Month Follow-Up	-11.67 score on a scale Standard Deviation 4.566
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: Cycle 3	-9.56 score on a scale Standard Deviation 18.196
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: Cycle 6	-8.30 score on a scale Standard Deviation 20.039
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: EOT/Early Discontinuation	-10.02 score on a scale Standard Deviation 20.371
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: Response Visit	-12.67 score on a scale Standard Deviation 18.019
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 3-Month Follow-Up	-12.20 score on a scale Standard Deviation 18.630
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 6-Month Follow-Up	-10.13 score on a scale Standard Deviation 16.699
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 9-Month Follow-Up	-12.28 score on a scale Standard Deviation 18.478
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 12-Month Follow-Up	-8.62 score on a scale Standard Deviation 18.297
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 15-Month Follow-Up	-9.05 score on a scale Standard Deviation 19.284
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 18-Month Follow-Up	-10.41 score on a scale Standard Deviation 20.632
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 21-Month Follow-Up	-9.16 score on a scale Standard Deviation 21.398
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 24-Month Follow-Up	-10.71 score on a scale Standard Deviation 17.675
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 27-Month Follow-Up	-11.41 score on a scale Standard Deviation 19.904
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Disease Symptoms: 30-Month Follow-Up	-5.00 score on a scale Standard Deviation 20.917
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: Cycle 3	6.20 score on a scale Standard Deviation 18.182
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: Cycle 6	4.11 score on a scale Standard Deviation 16.406
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: EOT/Early Discontinuation	1.65 score on a scale Standard Deviation 15.199
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: Response Visit	0.76 score on a scale Standard Deviation 17.528
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 3-Month Follow-Up	2.59 score on a scale Standard Deviation 20.779
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 6-Month Follow-Up	3.46 score on a scale Standard Deviation 23.611
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 9-Month Follow-Up	1.45 score on a scale Standard Deviation 17.135
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 12-Month Follow-Up	4.42 score on a scale Standard Deviation 22.269
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 15-Month Follow-Up	2.86 score on a scale Standard Deviation 19.602
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 18-Month Follow-Up	2.62 score on a scale Standard Deviation 22.532
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 21-Month Follow-Up	2.78 score on a scale Standard Deviation 18.502
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 24-Month Follow-Up	0.89 score on a scale Standard Deviation 15.134
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 27-Month Follow-Up	1.45 score on a scale Standard Deviation 14.731
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Infection: 30-Month Follow-Up	-5.00 score on a scale Standard Deviation 9.502
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: Cycle 3	-3.92 score on a scale Standard Deviation 28.827
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: Cycle 6	-3.95 score on a scale Standard Deviation 34.412
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: EOT/Early Discont.	-6.41 score on a scale Standard Deviation 33.141
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: Response Visit	-9.24 score on a scale Standard Deviation 33.054
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 3-Month Follow-Up	-11.87 score on a scale Standard Deviation 27.983
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 6-Month Follow-Up	-4.69 score on a scale Standard Deviation 33.527
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 9-Month Follow-Up	-13.33 score on a scale Standard Deviation 28.033
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 12-Month Follow-Up	-7.89 score on a scale Standard Deviation 27.145
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 15-Month Follow-Up	-6.76 score on a scale Standard Deviation 34.099
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 18-Month Follow-Up	-5.71 score on a scale Standard Deviation 31.583
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 21-Month Follow-Up	-4.55 score on a scale Standard Deviation 32.495
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 24-Month Follow-Up	-11.51 score on a scale Standard Deviation 28.845
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 27-Month Follow-Up	-9.42 score on a scale Standard Deviation 29.534
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Social Activities: 30-Month Follow-Up	0.00 score on a scale Standard Deviation 66.668
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: Cycle 3	-20.08 score on a scale Standard Deviation 30.329
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: Cycle 6	-14.04 score on a scale Standard Deviation 29.946
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: EOT/Early Discont.	-18.57 score on a scale Standard Deviation 32.794
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: Response Visit	-20.24 score on a scale Standard Deviation 28.351
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 3-Month Follow-Up	-25.11 score on a scale Standard Deviation 29.805
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 6-Month Follow-Up	-17.44 score on a scale Standard Deviation 30.680
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 9-Month Follow-Up	-23.47 score on a scale Standard Deviation 27.253
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 12-Month Follow-Up	-19.23 score on a scale Standard Deviation 26.053
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 15-Month Follow-Up	-17.14 score on a scale Standard Deviation 33.929
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 18-Month Follow-Up	-19.72 score on a scale Standard Deviation 34.540
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 21-Month Follow-Up	-21.21 score on a scale Standard Deviation 27.820
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 24-Month Follow-Up	-21.82 score on a scale Standard Deviation 30.911
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 27-Month Follow-Up	-25.36 score on a scale Standard Deviation 31.572
Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score Future Health Worries: 30-Month Follow-Up	-6.67 score on a scale Standard Deviation 27.892

SECONDARY outcome

Timeframe: Day 1 up to 46 months

Population: The safety population included participants who received any amount of study treatment.

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Number of Hospitalizations Due to Adverse Events (AEs)	1.43 hospitalizations Standard Deviation 0.634

SECONDARY outcome

Timeframe: Day 1 up to 46 months

Population: The safety population included participants who received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Obinutuzumab + Bendamustine (BG) n=102 Participants Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Percentage of Participants With Adverse Events (AEs)	100 percentage of participants

Adverse Events

Obinutuzumab + Bendamustine (BG)

Serious events: 31 serious events

Other events: 101 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Obinutuzumab + Bendamustine (BG) n=102 participants at risk Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Blood and lymphatic system disorders Febrile neutropenia	3.9% 4/102 • Number of events 4 • Day 1 up to 46 months
Blood and lymphatic system disorders Anaemia	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Cardiac disorders Cardiac arrest	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Cardiac disorders Myocardial infarction	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Gastrointestinal disorders Vomiting	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
General disorders Pyrexia	4.9% 5/102 • Number of events 5 • Day 1 up to 46 months
Infections and infestations Pneumonia	6.9% 7/102 • Number of events 8 • Day 1 up to 46 months
Infections and infestations Urinary tract infection	2.0% 2/102 • Number of events 2 • Day 1 up to 46 months
Infections and infestations Catheter site infection	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Infections and infestations Infection	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Infections and infestations Oesophageal candidiasis	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Infections and infestations Septic shock	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Injury, poisoning and procedural complications Infusion related reaction	2.0% 2/102 • Number of events 2 • Day 1 up to 46 months
Investigations Blood creatinine increased	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Metabolism and nutrition disorders Dehydration	2.9% 3/102 • Number of events 3 • Day 1 up to 46 months
Metabolism and nutrition disorders Tumour lysis syndrome	3.9% 4/102 • Number of events 4 • Day 1 up to 46 months
Metabolism and nutrition disorders Failure to thrive	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Vascular disorders Hypotension	2.0% 2/102 • Number of events 2 • Day 1 up to 46 months
Cardiac disorders Cardiac failure congestive	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Infections and infestations Progressive multifocal leukoencephalopathy	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months
Infections and infestations Sepsis	0.98% 1/102 • Number of events 1 • Day 1 up to 46 months

Other adverse events

Other adverse events
Measure	Obinutuzumab + Bendamustine (BG) n=102 participants at risk Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles.
Blood and lymphatic system disorders Neutropenia	35.3% 36/102 • Number of events 53 • Day 1 up to 46 months
Blood and lymphatic system disorders Thrombocytopenia	19.6% 20/102 • Number of events 42 • Day 1 up to 46 months
Blood and lymphatic system disorders Anaemia	13.7% 14/102 • Number of events 18 • Day 1 up to 46 months
Gastrointestinal disorders Nausea	52.9% 54/102 • Number of events 74 • Day 1 up to 46 months
Gastrointestinal disorders Constipation	26.5% 27/102 • Number of events 29 • Day 1 up to 46 months
Gastrointestinal disorders Diarrhoea	23.5% 24/102 • Number of events 34 • Day 1 up to 46 months
Gastrointestinal disorders Vomiting	20.6% 21/102 • Number of events 33 • Day 1 up to 46 months
Gastrointestinal disorders Abdominal pain	10.8% 11/102 • Number of events 13 • Day 1 up to 46 months
Gastrointestinal disorders Dyspepsia	6.9% 7/102 • Number of events 7 • Day 1 up to 46 months
General disorders Fatigue	35.3% 36/102 • Number of events 48 • Day 1 up to 46 months
General disorders Pyrexia	34.3% 35/102 • Number of events 44 • Day 1 up to 46 months
General disorders Oedema peripheral	15.7% 16/102 • Number of events 16 • Day 1 up to 46 months
General disorders Chills	12.7% 13/102 • Number of events 13 • Day 1 up to 46 months
Infections and infestations Upper respiratory tract infection	13.7% 14/102 • Number of events 15 • Day 1 up to 46 months
Infections and infestations Bronchitis	5.9% 6/102 • Number of events 6 • Day 1 up to 46 months
Injury, poisoning and procedural complications Infusion related reaction	74.5% 76/102 • Number of events 96 • Day 1 up to 46 months
Investigations Neutrophil count decreased	14.7% 15/102 • Number of events 24 • Day 1 up to 46 months
Investigations Platelet count decreased	7.8% 8/102 • Number of events 15 • Day 1 up to 46 months
Investigations Weight decreased	7.8% 8/102 • Number of events 10 • Day 1 up to 46 months
Metabolism and nutrition disorders Dehydration	14.7% 15/102 • Number of events 18 • Day 1 up to 46 months
Metabolism and nutrition disorders Decreased appetite	11.8% 12/102 • Number of events 13 • Day 1 up to 46 months
Metabolism and nutrition disorders Hypokalaemia	8.8% 9/102 • Number of events 14 • Day 1 up to 46 months
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 6/102 • Number of events 7 • Day 1 up to 46 months
Metabolism and nutrition disorders Hyponatraemia	5.9% 6/102 • Number of events 6 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Arthralgia	12.7% 13/102 • Number of events 16 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Bone pain	7.8% 8/102 • Number of events 8 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 9/102 • Number of events 10 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Back pain	6.9% 7/102 • Number of events 7 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Muscle spasms	6.9% 7/102 • Number of events 7 • Day 1 up to 46 months
Nervous system disorders Headache	18.6% 19/102 • Number of events 24 • Day 1 up to 46 months
Nervous system disorders Dizziness	11.8% 12/102 • Number of events 16 • Day 1 up to 46 months
Nervous system disorders Dysgeusia	7.8% 8/102 • Number of events 8 • Day 1 up to 46 months
Psychiatric disorders Insomnia	18.6% 19/102 • Number of events 20 • Day 1 up to 46 months
Psychiatric disorders Anxiety	6.9% 7/102 • Number of events 7 • Day 1 up to 46 months
Respiratory, thoracic and mediastinal disorders Cough	16.7% 17/102 • Number of events 21 • Day 1 up to 46 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.8% 8/102 • Number of events 8 • Day 1 up to 46 months
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.9% 6/102 • Number of events 8 • Day 1 up to 46 months
Skin and subcutaneous tissue disorders Rash	27.5% 28/102 • Number of events 42 • Day 1 up to 46 months
Skin and subcutaneous tissue disorders Dry skin	9.8% 10/102 • Number of events 10 • Day 1 up to 46 months
Skin and subcutaneous tissue disorders Pruritus	6.9% 7/102 • Number of events 10 • Day 1 up to 46 months
Skin and subcutaneous tissue disorders Night sweats	5.9% 6/102 • Number of events 6 • Day 1 up to 46 months
Vascular disorders Flushing	6.9% 7/102 • Number of events 9 • Day 1 up to 46 months
Vascular disorders Hypotension	7.8% 8/102 • Number of events 8 • Day 1 up to 46 months
Infections and infestations Pneumonia	5.9% 6/102 • Number of events 6 • Day 1 up to 46 months
Musculoskeletal and connective tissue disorders Myalgia	6.9% 7/102 • Number of events 8 • Day 1 up to 46 months

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER