Trial Outcomes & Findings for A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON) (NCT NCT01300247)

NCT ID: NCT01300247

Last Updated: 2017-02-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)
• Results posted on: 2017-02-02

Participant Flow

Participant milestones

Measure	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).	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).
Overall Study STARTED	21	20
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	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).	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).
Overall Study Death	1	1
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	0
Overall Study Non-Compliance	0	1

Baseline Characteristics

A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

Baseline characteristics by cohort

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).	Total n=41 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 11.1 • n=5 Participants	62.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	59.8 years STANDARD_DEVIATION 10.2 • n=5 Participants
Gender Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)

Population: Safety evaluable population

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Number of Participants With Human Anti-Human Antibodies (HAHAs)	0 participants	0 participants

SECONDARY outcome

Timeframe: 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)

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: Safety evaluable population

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.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines	61.9 percentage of participants Interval 38.44 to 81.89	90.0 percentage of participants Interval 68.3 to 98.77

SECONDARY outcome

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

Population: Safety evaluable population.

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.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines	NA percentage of participants Not estimated as not enough data captured in this arm at 6 months	100.00 percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

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

Population: Safety evaluable population.

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.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Percentage of Participants Who Were Alive and Progression Free	90.5 percentage of participants	90.0 percentage of participants

SECONDARY outcome

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

Population: Safety evaluable population.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Percentage of Participants Who Were Alive	95.2 percentage of participants	95.0 percentage of participants

SECONDARY outcome

Timeframe: 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)

Population: Safety evaluable population

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.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Percentage of Participants Who Had B-Cell Depletion End of the treatment period	90.5 percentage of participants	100.0 percentage of participants
Percentage of Participants Who Had B-Cell Depletion Follow-up at 6 months	85.7 percentage of participants	100.0 percentage of participants
Percentage of Participants Who Had B-Cell Depletion Within 6-12 months of follow-up	81.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Who Had B-Cell Depletion After 12 months follow-up	47.6 percentage of participants	70.0 percentage of participants

SECONDARY outcome

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

Population: Safety evaluable population

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.

Outcome measures

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 Participants 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).	Obinutuzumab + Bendamustine n=20 Participants 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).
Percentage of Participants Who Had B-Cell Recovery Follow-up at 6 months	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Had B-Cell Recovery Within 6-12 months of follow-up	9.5 percentage of participants	0 percentage of participants
Percentage of Participants Who Had B-Cell Recovery After 12 months follow-up	42.9 percentage of participants	30.0 percentage of participants

Adverse Events

Obinutuzumab + Fludarabine + Cyclophosphamide

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Obinutuzumab + Bendamustine

Serious events: 11 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 participants at risk 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).	Obinutuzumab + Bendamustine n=20 participants at risk 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).
Infections and infestations Cellulitis	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 3/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Appendicitis	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Pneumonia	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Skin infection	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Nausea	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Diarrhoea	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Pyrexia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Fatigue	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Cardiac disorders Tachycardia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Neutrophil count decreased	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Syncope	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Psychiatric disorders Mental status changes	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Hypertension	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Neutropenia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.

Other adverse events

Measure	Obinutuzumab + Fludarabine + Cyclophosphamide n=21 participants at risk 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).	Obinutuzumab + Bendamustine n=20 participants at risk 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).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Gout	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Bone pain	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	20.0% 4/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Headache	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Memory impairment	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Aphonia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Balance disorder	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Muscular weakness	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Disturbance in attention	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Hypoaesthesia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Dizziness	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Neutropenia	23.8% 5/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	50.0% 10/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Anaemia	23.8% 5/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 3/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Febrile neutropenia	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Cytopenia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Cardiac disorders Tachycardia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Eye disorders Vision blurred	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Nausea	76.2% 16/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	60.0% 12/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Constipation	47.6% 10/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	35.0% 7/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Vomiting	33.3% 7/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Diarrhoea	19.0% 4/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	50.0% 10/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Epigastric discomfort	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Abdominal distension	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Mouth ulceration	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Gastrointestinal disorders Stomatitis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Fatigue	57.1% 12/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	35.0% 7/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Pyrexia	23.8% 5/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	40.0% 8/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Chills	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	35.0% 7/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Oedema peripheral	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Asthenia	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Injection site pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Axillary pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Catheter site pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Chest discomfort	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Malaise	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Mucosal inflammation	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Immune system disorders Drug hypersensitivity	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Immune system disorders Cytokine release syndrome	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Immune system disorders Hypersensitivity	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Upper respiratory tract infection	19.0% 4/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Sinusitis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Urinary tract infection	14.3% 3/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Bronchitis	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Candida infection	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Paronychia	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Tooth infection	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Clostridium difficile infection	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Herpes zoster	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Pharyngitis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Infections and infestations Pneumonia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Alanine aminotransferase increased	19.0% 4/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Aspartate aminotransferase increased	14.3% 3/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Blood creatinine increased	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Electrocardiogram QT prolonged	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Investigations Transaminases increased	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Dehydration	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Muscle contractions involuntary	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Neuropathy peripheral	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Restless leg syndrome	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Nervous system disorders Somnolence	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Psychiatric disorders Insomnia	19.0% 4/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Psychiatric disorders Anxiety	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Psychiatric disorders Communication disorder	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Psychiatric disorders Depression	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Renal and urinary disorders Pollakiuria	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Renal and urinary disorders Dysuria	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	30.0% 6/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 3/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	15.0% 3/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	25.0% 5/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	20.0% 4/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Erythema	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Dry skin	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Pruritus generalized	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash pruritic	9.5% 2/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	0.00% 0/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Acne	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Flushing	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	20.0% 4/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Hypotension	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Phlebitis	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Haematoma	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Hypertension	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Intermittent claudication	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Vascular disorders Phlebitis superficial	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	10.0% 2/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Injury, poisoning and procedural complications Infusion related reaction	76.2% 16/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	55.0% 11/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Injury, poisoning and procedural complications Contusion	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
General disorders Adverse drug reaction	4.8% 1/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Surgical and medical procedures Radiotherapy	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.
Surgical and medical procedures Sinus operation	0.00% 0/21 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.	5.0% 1/20 • Up to the end of the study (up to approximately 4 years). All adverse events (related and unrelated to treatment) were to be collected up to 28 days after the last dose of obinutuzumab. After 28 days after the last dose of obinutuzumab, investigators were to report only serious adverse events that were attributed to obinutuzumab; these were to be reported to Genentech/Roche Drug Safety indefinitely (even if the study was closed). Significant abnormalities in laboratory parameters were reported as adverse events.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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