Trial Outcomes & Findings for Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation (NCT NCT02867384)
NCT ID: NCT02867384
Last Updated: 2026-02-19
Results Overview
Corticosteroid-requiring cGVHD is defined as the 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
2026-02-19
Participant Flow
Participants were enrolled at 5 clinical sites in the U.S. from November 29, 2016 to January 30, 2023.
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
|
90
|
88
|
0
|
|
Overall Study
COMPLETED
|
39
|
30
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
58
|
3
|
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
|
Never Received Treatment
Some patients never received any treatment and got randomized after enrollment.
|
|---|---|---|---|
|
Overall Study
GVHD requiring change in Treatment Medication
|
14
|
30
|
0
|
|
Overall Study
Progression/ Relapse
|
15
|
19
|
0
|
|
Overall Study
Adverse Event
|
13
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Patient compliance
|
1
|
0
|
0
|
|
Overall Study
Intercurrent illness or uncontrolled infection
|
1
|
1
|
0
|
|
Overall Study
Never start treatment
|
0
|
0
|
3
|
Baseline Characteristics
Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation
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=4 Participants
|
63 years
|
62 years
n=4 Participants
|
63 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=4 Participants
|
33 Participants
|
2 Participants
n=4 Participants
|
67 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=4 Participants
|
55 Participants
|
1 Participants
n=4 Participants
|
114 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
76 Participants
n=4 Participants
|
79 Participants
|
2 Participants
n=4 Participants
|
157 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=4 Participants
|
2 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=4 Participants
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
More Than One Race
|
4 Participants
n=4 Participants
|
2 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=4 Participants
|
3 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The analysis only included patients who started treatment.
Corticosteroid-requiring cGVHD is defined as the 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
| 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
|
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
|
|---|---|---|
|
Corticosteroid-Requiring Chronic Graft-Versus-Host Disease (cGVHD) Rate
|
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 2 yearsPopulation: The analysis only included patients who started treatment.
All cGVHD rate is defined as the percentage of participants who develop chronic Graft Versus Host Disease cGVHD following Hematopoietic Cell Transplantation HCT.
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
|
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
|
|---|---|---|
|
All Chronic Graft-Versus-Host Disease (cGVHD) Rate
at 1 year
|
40 percentage of participants
Interval 30.0 to 50.0
|
48 percentage of participants
Interval 37.0 to 58.0
|
|
All Chronic Graft-Versus-Host Disease (cGVHD) Rate
at 2 years
|
62 percentage of participants
Interval 49.0 to 69.0
|
58 percentage of participants
Interval 47.0 to 68.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis only included patients who started treatment.
IFS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first. Participants who are alive without relapse and who have not initiated systemic immunosuppression will be censored at the date of last disease or survival assessment.
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
|
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
|
|---|---|---|
|
Immunosuppression-Free Survival at 1 Year (IFS1)
|
69 percentage probability
Interval 58.0 to 77.0
|
43 percentage probability
Interval 32.0 to 53.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis only included patients who started treatment.
IFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. IFS is defined as time from randomization to relapse, institution of systemic immune suppression, or death, whichever occurs first. Participants who are alive without relapse and who have not initiated systemic immunosuppression will be censored at the date of last disease or survival assessment.
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
|
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
|
|---|---|---|
|
Immunosuppression-Free Survival at 2 Years (IFS2)
|
46 percentage probability
Interval 35.0 to 56.0
|
33 percentage probability
Interval 23.0 to 43.0
|
SECONDARY outcome
Timeframe: at 1 year and at 2 yearsPopulation: The analysis only included patients who started treatment.
NIH moderate-severe cGVHD rate is defined as the percentage of participants who developed NIH moderate-severe cGVHD following Hematopoietic Cell Transplantation HCT.
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
|
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
|
|---|---|---|
|
NIH Moderate-Severe Chronic Graft-Versus-Host Disease (cGVHD) Rate
at 1 year
|
24.5 percentage of participants
Interval 16.0 to 34.0
|
48 percentage of participants
Interval 37.0 to 58.0
|
|
NIH Moderate-Severe Chronic Graft-Versus-Host Disease (cGVHD) Rate
at 2 years
|
33 percentage of participants
Interval 24.0 to 43.0
|
41.5 percentage of participants
Interval 31.0 to 52.0
|
SECONDARY outcome
Timeframe: at 1 year and at 2 yearsPopulation: The analysis only included patients who started treatment.
Cumulative incidence of NRM is defined as the probability of death from any cause other than disease relapse or progression following treatment or transplantation. Deaths due to relapse or disease progression are treated as competing events. Participants who are alive without relapse or death are censored at the date of last follow-up.
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
|
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
|
|---|---|---|
|
Cumulative Incidence Of Non-Relapse Mortality (NRM)
at 1 year
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Cumulative Incidence Of Non-Relapse Mortality (NRM)
at 2 years
|
6.7 percentage of participants
Interval 2.7 to 13.0
|
1.2 percentage of participants
Interval 0.1 to 5.6
|
SECONDARY outcome
Timeframe: at 1 year and 2 yearsPopulation: The analysis only included patients who started treatment.
Cumulative Incidence of Relapse is defined as the percentage probability of disease relapse following treatment, with death without prior relapse treated as a competing risk. Patients who are alive and relapse-free at last follow-up will be censored.
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
|
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
|
|---|---|---|
|
Cumulative Incidence of Relapse
at 1 year
|
18 percentage probability
Interval 11.0 to 26.0
|
21.6 percentage probability
Interval 14.0 to 31.0
|
|
Cumulative Incidence of Relapse
at 2 years
|
21.1 percentage probability
Interval 13.0 to 30.0
|
26.2 percentage probability
Interval 17.0 to 36.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis only included patients who started treatment.
PFS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Patients who are alive without disease progression at the time of last disease assessment will be censored at that date.
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
|
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
|
|---|---|---|
|
Progression-Free Survival at 1 Year (PFS1)
|
82 percentage probability
Interval 73.0 to 89.0
|
78 percentage probability
Interval 68.0 to 86.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis only included patients who started treatment.
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Patients who are alive without disease progression at the time of last disease assessment will be censored at that date.
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
|
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
|
|---|---|---|
|
Progression-Free Survival at 2 Years (PFS2)
|
72 percentage probability
Interval 62.0 to 80.0
|
73 percentage probability
Interval 62.0 to 81.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis only included patients who started treatment.
OS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of last follow-up will be censored at the date of last contact.
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
|
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
|
|---|---|---|
|
Overall Survival at 1 Year (OS1)
|
96 percentage probability
Interval 89.0 to 98.0
|
93 percentage probability
Interval 85.0 to 97.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis only included patients who started treatment.
OS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. OS is defined as the time from randomization to death from any cause. Participants who are alive at the time of last follow-up will be censored at the date of last contact.
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
|
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
|
|---|---|---|
|
Overall Survival at 2 Years (OS2)
|
84 percentage probability
Interval 75.0 to 90.0
|
85 percentage probability
Interval 76.0 to 91.0
|
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
| 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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.8%
43/90 • 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.
|
34.1%
30/88 • 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.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
10.0%
9/90 • 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.
|
|
Cardiac disorders
Acute coronary syndrome
|
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
Atrial fibrillation
|
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.
|
|
Cardiac disorders
Atrial flutter
|
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.
|
|
Cardiac disorders
Cardiac disorders - 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.
|
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.
|
|
Ear and labyrinth disorders
Hearing impaired
|
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.
|
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
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.
|
|
Ear and labyrinth disorders
Vertigo
|
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.
|
|
Ear and labyrinth disorders
Ear and labyrinth 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.
|
|
Endocrine disorders
Hypoparathyroidism
|
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.
|
|
Endocrine disorders
Hypothyroidism
|
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.
|
|
Eye disorders
Blurred vision
|
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.
|
|
Eye disorders
Cataract
|
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.
|
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.
|
|
Eye disorders
Dry eye
|
17.8%
16/90 • 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.
|
38.6%
34/88 • 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 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.
|
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.
|
|
Eye disorders
Flashing lights
|
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
Floaters
|
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.
|
|
Eye disorders
Papilledema
|
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.
|
|
Eye disorders
Photophobia
|
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.
|
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.
|
|
Eye disorders
Scleral disorder
|
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.
|
|
Eye disorders
Watering eyes
|
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
|
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.
|
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
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.
|
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.
|
|
Gastrointestinal disorders
Constipation
|
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.
|
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.
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
24/90 • 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.
|
18.2%
16/88 • 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
Dry mouth
|
10.0%
9/90 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
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.
|
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.
|
|
Gastrointestinal disorders
Dysphagia
|
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.
|
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.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
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.
|
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.
|
|
Gastrointestinal disorders
Hemorrhoids
|
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
Lip pain
|
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
Mucositis oral
|
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.
|
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.
|
|
Gastrointestinal disorders
Nausea
|
32.2%
29/90 • 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.
|
26.1%
23/88 • 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
Oral dysesthesia
|
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.
|
|
Gastrointestinal disorders
Oral 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.
|
|
Gastrointestinal disorders
Oral pain
|
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.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
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.
|
|
Gastrointestinal disorders
Rectal pain
|
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.
|
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
Small intestinal obstruction
|
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
Stomach pain
|
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.
|
|
Gastrointestinal disorders
Toothache
|
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
Vomiting
|
7.8%
7/90 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
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.
|
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
Chills
|
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.
|
|
General disorders and administration site conditions
Edema face
|
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.
|
|
General disorders and administration site conditions
Edema limbs
|
20.0%
18/90 • 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.
|
20.5%
18/88 • 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
Fatigue
|
54.4%
49/90 • 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.
|
56.8%
50/88 • 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
Fever
|
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.
|
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.
|
|
General disorders and administration site conditions
Flu like symptoms
|
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.
|
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.
|
|
General disorders and administration site conditions
Infusion related reaction
|
27.8%
25/90 • 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.
|
|
General disorders and administration site conditions
Localized edema
|
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.
|
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.
|
|
General disorders and administration site conditions
Multi-organ 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.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
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.
|
|
General disorders and administration site conditions
Pain
|
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.
|
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.
|
|
Hepatobiliary disorders
Gallbladder pain
|
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.
|
|
Hepatobiliary disorders
Hepatic pain
|
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.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
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.
|
|
Infections and infestations
Eye infection
|
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.
|
|
Infections and infestations
Lung infection
|
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.
|
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.
|
|
Infections and infestations
Meningitis
|
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.
|
|
Infections and infestations
Otitis media
|
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.
|
|
Infections and infestations
Papulopustular rash
|
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.
|
|
Infections and infestations
Rhinitis infective
|
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
Sinusitis
|
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.
|
|
Infections and infestations
Skin infection
|
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.
|
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
Tooth infection
|
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.
|
|
Infections and infestations
Upper respiratory infection
|
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.
|
|
Infections and infestations
Urinary tract infection
|
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.
|
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
|
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.
|
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.
|
|
Injury, poisoning and procedural complications
Bruising
|
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.
|
|
Injury, poisoning and procedural complications
Burn
|
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.
|
|
Injury, poisoning and procedural complications
Fall
|
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.
|
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.
|
|
Injury, poisoning and procedural complications
Fracture
|
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.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
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.
|
|
Investigations
Alanine aminotransferase increased
|
45.6%
41/90 • 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.
|
64.8%
57/88 • 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
Alkaline phosphatase increased
|
42.2%
38/90 • 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.
|
43.2%
38/88 • 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
Aspartate aminotransferase increased
|
37.8%
34/90 • 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.
|
55.7%
49/88 • 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
Blood bilirubin increased
|
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.
|
|
Investigations
Blood corticotrophin 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.
|
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.
|
|
Investigations
Cholesterol high
|
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.
|
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
Creatinine increased
|
41.1%
37/90 • 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.
|
28.4%
25/88 • 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
|
96.7%
87/90 • 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.
|
29.5%
26/88 • 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
|
96.7%
87/90 • 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.
|
50.0%
44/88 • 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
Urine output 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.
|
|
Investigations
Weight gain
|
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.
|
|
Investigations
Weight loss
|
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.
|
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.
|
|
Investigations
White blood cell decreased
|
71.1%
64/90 • 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.
|
26.1%
23/88 • 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
Investigations - Other, specify
|
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.
|
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
Anorexia
|
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.
|
17.0%
15/88 • 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
Dehydration
|
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
Hypercalcemia
|
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
Hyperglycemia
|
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.
|
|
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.
|
|
Psychiatric disorders
Anxiety
|
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.
|
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.
|
|
Psychiatric disorders
Confusion
|
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
Depression
|
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.
|
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.
|
|
Psychiatric disorders
Insomnia
|
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.
|
6.8%
6/88 • 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
Psychiatric 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.
|
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.
|
|
Renal and urinary disorders
Chronic kidney disease
|
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.
|
|
Renal and urinary disorders
Urinary frequency
|
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.
|
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.
|
|
Renal and urinary disorders
Urinary incontinence
|
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.
|
|
Renal and urinary disorders
Urinary retention
|
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
Urinary tract obstruction
|
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 and urinary disorders - 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.
|
|
Reproductive system and breast disorders
Breast 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.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
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.
|
|
Reproductive system and breast disorders
Scrotal pain
|
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.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
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.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
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.
|
|
Reproductive system and breast disorders
Vaginal 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.
|
|
Reproductive system and breast disorders
Reproductive system and breast 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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.8%
16/90 • 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.
|
14.8%
13/88 • 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
|
23.3%
21/90 • 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.
|
19.3%
17/88 • 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
Hoarseness
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
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
Nasal congestion
|
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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
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
|
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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
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
Pulmonary hypertension
|
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
Sore throat
|
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
Respiratory, thoracic and mediastinal disorders - 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.
|
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
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.
|
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.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
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.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
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.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
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.
|
13.6%
12/88 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.6%
23/90 • 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.
|
20.5%
18/88 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
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.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
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.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
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.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
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.
|
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.
|
|
Vascular disorders
Hot flashes
|
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.
|
|
Vascular disorders
Hypertension
|
23.3%
21/90 • 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.
|
20.5%
18/88 • 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
Hypotension
|
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.
|
|
Vascular disorders
Lymphedema
|
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
Thromboembolic event
|
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.
|
|
Vascular disorders
Vascular 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place