Trial Outcomes & Findings for Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation (NCT NCT02867384)

Last Updated: 2025-10-07

Results Overview

Percentage of participants who develop chronic Graft Versus Host Disease cGVHD requiring treatment with corticosteroids within the first year following Hematopoietic Cell Transplantation HCT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

181 participants

Primary outcome timeframe

1 year

Results posted on

2025-10-07

Participant Flow

Participants were enrolled at 5 clinical sites in the U.S. from November 29, 2016 to January 30, 2023.

Participant milestones

Participant milestones
Measure	Obinutuzumab Obinutuzumab will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo	Never received treatment Some patients never received any treatment and got randomized after enrollment.
Overall Study STARTED	90	88	3
Overall Study Randomized	0	88	90
Overall Study COMPLETED	39	30	0
Overall Study NOT COMPLETED	51	58	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Obinutuzumab Obinutuzumab will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo
Overall Study GVHD requiring change in Treatment Medication	14	30
Overall Study Progression/ Relapse	15	19
Overall Study Adverse Event	13	1
Overall Study Withdrawal by Subject	6	5
Overall Study Physician Decision	1	2
Overall Study Patient compliance	1	0
Overall Study Intercurrent illness or uncontrolled infection	1	1
Overall Study Never start treatment	3	0

Baseline Characteristics

Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obinutuzumab n=90 Participants Obinutuzumab will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo n=88 Participants Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo	Never received treatment n=3 Participants Some patients never received any treatment and got randomized after enrollment.	Total n=181 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants	63 years n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	2 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	55 Participants n=7 Participants	1 Participants n=5 Participants	114 Participants n=4 Participants
Race/Ethnicity, Customized White	76 Participants n=5 Participants	79 Participants n=7 Participants	2 Participants n=5 Participants	157 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized More Than One Race	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The analysis only included patients who started treatment.

Percentage of participants who develop chronic Graft Versus Host Disease cGVHD requiring treatment with corticosteroids within the first year following Hematopoietic Cell Transplantation HCT.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=90 Participants Obinutuzumab or will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo n=88 Participants Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo
Rate Of Corticosteroid-Requiring cGVHD At One Year From HCT	13.3 percentage of participants Interval 7.1 to 22.1	35.2 percentage of participants Interval 25.3 to 46.0

SECONDARY outcome

Timeframe: at 1 year and at 2 years

A secondary endpoint of this phase II trial is the overall rate cGVHD one and two years after HCT.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 1 year and at 2 years

IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 1 year and at 2 years

A secondary endpoint is the rate of NIH Moderate-Severe cGVHD one and two years after HCT.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 1 year and at 2 years

A secondary endpoint is the cumulative incidence of non-relapse mortality and relapse one and two years after HCT.

Outcome measures

Outcome data not reported

Adverse Events

Obinutuzumab

Serious events: 28 serious events

Other events: 87 other events

Deaths: 29 deaths

Placebo

Serious events: 12 serious events

Other events: 81 other events

Deaths: 28 deaths

Serious adverse events

Other adverse events

Additional Information

Corey Cutler, MD

Dana-Farber Cancer Institute

Phone: 6176323470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Obinutuzumab n=90 participants at risk Obinutuzumab will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo n=88 participants at risk Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo
Blood and lymphatic system disorders Febrile neutropenia	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Cardiac disorders Heart failure	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Eye disorders Eye disorders - Other, specify	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Gastrointestinal disorders Abdominal pain	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Gastrointestinal disorders Diarrhea	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Gastrointestinal disorders Gastric hemorrhage	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
General disorders and administration site conditions Infusion related reaction	4.4% 4/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Infections and infestations Lung infection	3.3% 3/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	3.4% 3/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Infections and infestations Sepsis	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Infections and infestations Upper respiratory infection	3.3% 3/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Infections and infestations Infections and infestations - Other, specify	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Investigations Neutrophil count decreased	15.6% 14/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	4.5% 4/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Investigations Platelet count decreased	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Investigations White blood cell decreased	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Seizure	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Psychiatric disorders Depression	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Psychiatric disorders Suicidal ideation	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Renal and urinary disorders Renal colic	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Respiratory, thoracic and mediastinal disorders Productive cough	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Vascular disorders Visceral arterial ischemia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.

Other adverse events
Measure	Obinutuzumab n=90 participants at risk Obinutuzumab will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Obinutuzumab: B cell depletion	Placebo n=88 participants at risk Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. * Premedication with histamine blockers and acetaminophen will be provided * All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials Placebo: Placebo
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypertriglyceridemia	5.6% 5/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	3.4% 3/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypoalbuminemia	4.4% 4/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypocalcemia	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypokalemia	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	5.7% 5/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypomagnesemia	14.4% 13/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	9.1% 8/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hyponatremia	5.6% 5/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	9.1% 8/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Hypophosphatemia	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Iron overload	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Arthralgia	12.2% 11/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	8.0% 7/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Arthritis	3.3% 3/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Back pain	11.1% 10/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	11.4% 10/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Bone pain	4.4% 4/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.7% 6/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	3.4% 3/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	3.3% 3/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	3.4% 3/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Myalgia	15.6% 14/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	10.2% 9/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Myositis	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Neck pain	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	2.2% 2/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	8.0% 7/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Cognitive disturbance	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Concentration impairment	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Dizziness	5.6% 5/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	4.5% 4/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Dysarthria	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Dysgeusia	11.1% 10/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	12.5% 11/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Extrapyramidal disorder	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Headache	8.9% 8/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	15.9% 14/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Intracranial hemorrhage	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Memory impairment	1.1% 1/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	0.00% 0/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Paresthesia	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	2.3% 2/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Peripheral sensory neuropathy	12.2% 11/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	10.2% 9/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Nervous system disorders Tremor	4.4% 4/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.
Psychiatric disorders Agitation	0.00% 0/90 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.	1.1% 1/88 • Adverse events (AEs) were followed for 2 years. Deaths were monitored until 84.7 months. SAE is defined as an AE that results in: death or life-threatening illness; persistent or significant disability; a congenital anomaly/birth defect in an infant born to an Obinutuzumab-exposed mother or requires inpatient hospitalization or is considered a significant medical event by the investigator based on medical judgment. The analysis population is comprised of all randomized and treated patients. Only randomized and treated patients were monitored/assessed for AEs and All-Cause Mortality.