A Study of Obinutuzumab (GA101; RO5072759) in Combination... | NCT01300247

NCT01300247

ID	Type	Description	Link
GO01298	Other Identifier	Hoffmann-La Roche

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obinutuzumab + Fludarabine + Cyclophosphamide	Experimental	Participants will receive 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6), and cyclophosphamide (250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6).	Drug: Fludarabine Drug: Obinutuzumab Drug: Cyclophosphamide
Obinutuzumab + Bendamustine	Experimental	Participants will receive 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).	Drug: Obinutuzumab Drug: Bendamustine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludarabine	Drug	Participants will receive 6 cycles (each 28-day cycle) of fludarabine at dose of 25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Human Anti-Human Antibodies (HAHAs)		Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of CD20-positive B-CLL
Rai Stage III/IV or Binet Stage C disease
Rai Stage I/II or Binet Stage B disease that requires treatment
Adequate baseline bone marrow function, unless there is clear evidence of extensive bone marrow involvement with tumor infiltration, myelodysplasia, or hypocellularity
No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy of greater than (>) 6 months

Exclusion Criteria:

Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
Transformation of CLL to aggressive B-cell malignancy
Creatinine clearance less than equal to (<=) 60 milliliters per minute (mL/min), calculated according to the formula of Cockcroft and Gault
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN)
Total bilirubin greater than equal to (>=) 3 x ULN
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
History of sensitivity to mannitol (if bendamustine is to be administered)
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Known infection with human immunodeficiency virus (HIV) seropositive status
Presence of positive test results for hepatitis B (hepatitis B virus [HBV] surface antigen [HBsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody serology testing). Participants with chronic HBV infection, occult HBV infection, or past HBV infection will be excluded. Participants who have received IV immunoglobulin within 3 months of enrollment and who are anti-HBc positive but HBV deoxyribonucleic acid (DNA) negative will be considered for inclusion on the study by the Medical Monitor on a case-by-case basis. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
Women who are pregnant or lactating
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Concurrent (or within 7 days prior to the first dose of study treatment) systemic corticosteroid use except low-dose corticosteroid therapy used to treat an illness other than lymphoma

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama	35805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25769620	Derived	Brown JR, O'Brien S, Kingsley CD, Eradat H, Pagel JM, Lymp J, Hirata J, Kipps TJ. Obinutuzumab plus fludarabine/cyclophosphamide or bendamustine in the initial therapy of CLL patients: the phase 1b GALTON trial. Blood. 2015 Apr 30;125(18):2779-85. doi: 10.1182/blood-2014-12-613570. Epub 2015 Mar 13.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Obinutuzumab + Fludarabine + Cyclophosphamide

Safety-Evaluable population included all participants who received any amount of study treatment.

Arm/Group Information

ID	Title	Description
BG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
BG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

The pharmacokinetic (PK) variables could not be calculated as the PK samples were not collected accurately.

Posted

Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Maximum Plasma Concentration (Cmax) of Obinutuzumab

The PK variables could not be calculated as the PK samples were not collected accurately.

Posted

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Units	Counts
Participants

Secondary

Trough Plasma Concentration (Ctrough) of Obinutuzumab

The PK variables could not be calculated as the PK samples were not collected accurately.

Posted

Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Units	Counts
Participants

Secondary

Clearance of Obinutuzumab

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

The PK variables could not be calculated as the PK samples were not collected accurately.

Posted

Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Volume of Distribution of Obinutuzumab

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

The PK variables could not be calculated as the PK samples were not collected accurately.

Posted

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Half-Life of Obinutuzumab

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

The PK variables could not be calculated as the PK samples were not collected accurately.

Posted

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines

Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment.

Safety evaluable population

Posted

Number

95% Confidence Interval

percentage of participants

Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).

Secondary

Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines

DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery.

Safety evaluable population.

Posted

Number

95% Confidence Interval

percentage of participants

From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).

Secondary

Percentage of Participants Who Were Alive and Progression Free

Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology.

Safety evaluable population.

Posted

Number

percentage of participants

Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Percentage of Participants Who Were Alive

Safety evaluable population.

Posted

Number

percentage of participants

Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Units	Counts
Participants

Secondary

Percentage of Participants Who Had B-Cell Depletion

B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered.

Safety evaluable population

Posted

Number

percentage of participants

Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Secondary

Percentage of Participants Who Had B-Cell Recovery

B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants' CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment.

Safety evaluable population

Posted

Number

percentage of participants

Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)

ID	Title	Description
OG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
OG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Obinutuzumab + Fludarabine + Cyclophosphamide	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).			6	21	21	21
EG001	Obinutuzumab + Bendamustine	Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).			11	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected21 at risk EG0012 affected20 at risk
Appendicitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected20 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected20 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected20 at risk
Skin infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected20 at risk
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Fatigue	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected20 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Neutrophil count decreased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected20 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Mental status changes	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected21 at risk EG00110 affected20 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected21 at risk EG0013 affected20 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected21 at risk EG0015 affected20 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Cytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00016 affected21 at risk EG00112 affected20 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00010 affected21 at risk EG0017 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected21 at risk EG0012 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected21 at risk EG00110 affected20 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected20 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected20 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected20 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Fatigue	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00012 affected21 at risk EG0017 affected20 at risk
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected21 at risk EG0018 affected20 at risk
Chills	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0017 affected20 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected20 at risk
Pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected20 at risk
Asthenia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Injection site pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Axillary pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Catheter site pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Chest discomfort	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Malaise	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Mucosal inflammation	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected21 at risk EG0013 affected20 at risk
Sinusitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected20 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected20 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Candida infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Paronychia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Tooth infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Herpes zoster	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected21 at risk EG0011 affected20 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected21 at risk EG0011 affected20 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Transaminases increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0013 affected20 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0015 affected20 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected20 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0014 affected20 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0013 affected20 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected20 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0015 affected20 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0015 affected20 at risk
Memory impairment	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Aphonia	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Balance disorder	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Disturbance in attention	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Restless leg syndrome	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Somnolence	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Insomnia	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected21 at risk EG0013 affected20 at risk
Anxiety	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0015 affected20 at risk
Communication disorder	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0016 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected21 at risk EG0013 affected20 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0015 affected20 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected20 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected20 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Pruritus generalized	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected20 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Butterfly rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Rash generalized	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Flushing	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected20 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected20 at risk
Phlebitis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Haematoma	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Intermittent claudication	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Phlebitis superficial	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected20 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG00016 affected21 at risk EG00111 affected20 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Adverse drug reaction	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected20 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Radiotherapy	Surgical and medical procedures	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk
Sinus operation	Surgical and medical procedures	MedDRA 18.1	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected20 at risk

The interim data reported here (up to clinical cutoff date of 24 January 2013) were for participants who had completed treatment response assessment, which took place approximately 2 months after the last infusion of study treatment.

Certain Agreements

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C024352	fludarabine
C543332	obinutuzumab
D000069461	Bendamustine Hydrochloride
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D010752	Phosphoramide Mustards
D063088	Phosphoramides
D009943	Organophosphorus Compounds

Units	Counts
Participants	OG0000 OG0010