A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Mi... | NCT01414205

NCT01414205

ID	Type	Description	Link
GO25677	Other Identifier	Hoffmann-La Roche

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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 1000 mg	Experimental	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.	Drug: Obinutuzumab Drug: Corticosteroids
Obinutuzumab 2000 mg	Experimental	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.	Drug: Obinutuzumab Drug: Corticosteroids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obinutuzumab	Drug	Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes < 4 x 10^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin >11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils > 1.5 x 10^9/L or > 50% of pretreatment value, Platelets > 100 x 10^9/L or 50% of pretreatment value and Hemoglobin > 11 g/dL or > 50% of pretreatment value.	Week 32

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.	Up to 4 years, 5 months
Duration of Response

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr		Birmingham	Alabama	35291-3300	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26472752	Derived	Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
FG001	Obinutuzumab 2000 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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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 1000 mg

Obinutuzumab 2000 mg

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
BG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
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
	OG00048.8 OG00166.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.	0.0779		Difference (Hauck-Anderson)	17.89			2-Sided	95	-4.95	40.72					Superiority or Other

Secondary

Progression-free Survival (PFS)

PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.

Intent-to-treat population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts
Participants	OG000

Secondary

Duration of Response

Duration of response was not analyzed as investigators did not perform response assessments at regular intervals during the follow-up period.

Not Posted

Up to 4 years, 5 months

Participants

Secondary

Number of Participants Surviving at End-of-Study

Intent-to-treat population included all randomized participants.

Posted

Number

Participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.

Safety population included all randomized participants who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Secondary

Percentage of Participants With Adverse Events of Interest

Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.

Safety population included all randomized participants who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts
Participants

Secondary

Percentage of Participants With Adverse Events Leading to Study Discontinuation

Safety population included all randomized participants who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts
Participants

Secondary

PK Parameter: Maximum Serum Concentration (Cmax)

Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).

All randomized participants who received study drug with PK data available for analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Day 148 (at end of infusion)

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts

Secondary

PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )

Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day*μg/mL).

All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*μg/mL

Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Secondary

PK Parameter: Clearance at Steady State (CLss)

Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).

All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day

Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Secondary

PK Parameter: Volume of Distribution at Steady State (Vss)

All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Secondary

PK Parameter: Terminal Half-Life (t1/2)

All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.

Posted

Geometric Mean

Geometric Coefficient of Variation

Days

Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units

Secondary

PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)

Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).

All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.

Posted

Mean

Standard Deviation

μg/mL

Months 3, 6, 9, and 12

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts
Participants

Secondary

Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion

Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug has been administered.

Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.

Posted

Number

Participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Units	Counts

Secondary

Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery

Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.

Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.

Posted

Number

Participants

Up to 4 years, 5 months

ID	Title	Description
OG000	Obinutuzumab 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
OG001	Obinutuzumab 2000 mg

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 1000 mg	Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.			8	40	40	40
EG001	Obinutuzumab 2000 mg	Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.			8	38	38	38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Urosepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected38 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG00030 affected40 at risk EG00124 affected38 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG00016 affected40 at risk EG00118 affected38 at risk
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG00016 affected40 at risk EG00112 affected38 at risk
Chills	General disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected40 at risk EG0017 affected38 at risk
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected40 at risk EG0016 affected38 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00015 affected40 at risk EG00110 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00011 affected40 at risk EG0015 affected38 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0017 affected38 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0015 affected38 at risk
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00010 affected40 at risk EG0017 affected38 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00011 affected40 at risk EG0014 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00014 affected40 at risk EG00112 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0009 affected40 at risk EG0017 affected38 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected40 at risk EG0013 affected38 at risk
Flushing	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected40 at risk EG0019 affected38 at risk
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected40 at risk EG0014 affected38 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 affected40 at risk EG0016 affected38 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected40 at risk EG00111 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected40 at risk EG0018 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0016 affected38 at risk
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected40 at risk EG0017 affected38 at risk
Chest discomfort	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0014 affected38 at risk
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0010 affected38 at risk
Influenza like illness	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0013 affected38 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected38 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0014 affected38 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0014 affected38 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0012 affected38 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Dysgeusia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0013 affected38 at risk
Tremor	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0012 affected38 at risk
Memory impairment	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Somnolence	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0014 affected38 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0013 affected38 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0013 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0013 affected38 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected40 at risk EG0010 affected38 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0011 affected38 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected38 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0013 affected38 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0012 affected38 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0014 affected38 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0013 affected38 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected40 at risk EG0011 affected38 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0013 affected38 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0013 affected38 at risk
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0012 affected38 at risk
Fungal skin infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Rhinitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0012 affected38 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected40 at risk EG0013 affected38 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Lacrimation increased	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0012 affected38 at risk
Visual impairment	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0012 affected38 at risk
Nocturia	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected38 at risk
Blood magnesium decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected40 at risk EG0012 affected38 at risk
Chest Pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected38 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected38 at risk
Vision Blurred	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected40 at risk EG0012 affected38 at risk

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
C543332	obinutuzumab
D000305	Adrenal Cortex Hormones

Units	Counts
Participants	OG00026 OG00125

Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists