Trial Outcomes & Findings for A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) (NCT NCT01287741)

NCT ID: NCT01287741

Last Updated: 2019-04-12

Results Overview

Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1418 participants

Primary outcome timeframe

Baseline up to approximately 6.5 years (up to 31 January 2018)

Results posted on

2019-04-12

Participant Flow

A total of 1418 patients were randomized and included in the primary analyses (29 April 2016). A total of 1414 patients were included in the final analysis (31 January 2018), 710 in the R-CHOP arm and 704 in the G-CHOP arm; data from 4 patients were excluded because of serious GCP non-compliance at a single study site in China.

Participant milestones

Participant milestones
Measure
Rituximab+Chemotherapy
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Study
STARTED
712
706
Overall Study
COMPLETED
86
91
Overall Study
NOT COMPLETED
626
615

Reasons for withdrawal

Reasons for withdrawal
Measure
Rituximab+Chemotherapy
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Study
Withdrawal by Subject
35
38
Overall Study
Protocol Violation
2
0
Overall Study
Physician Decision
15
23
Overall Study
Non-compliance
8
6
Overall Study
Lost to Follow-up
10
8
Overall Study
Death
32
44
Overall Study
Adverse Event
4
6
Overall Study
Study terminated by Sponsor
307
315
Overall Study
Progressive disease
190
166
Overall Study
Reason not specified
23
9

Baseline Characteristics

A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Total
n=1414 Participants
Total of all reporting groups
Age, Continuous
59.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
59.4 years
STANDARD_DEVIATION 13.3 • n=7 Participants
59.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male
Female
328 Participants
n=5 Participants
336 Participants
n=7 Participants
664 Participants
n=5 Participants
Sex: Female, Male
Male
382 Participants
n=5 Participants
368 Participants
n=7 Participants
750 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Median Time to Progression-Free Survival (PFS), Investigator-Assessed
74.5 months
The 95% CI could not be estimated as too few participants had an event.
68.3 months
Interval 68.3 to
Upper bound of 95% CI could not be estimated as too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

Population: The intent-to-treat (ITT) population included all randomized participants.

Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 cm or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=712 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=706 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
NA months
Median and corresponding 95% CI could not be estimated as too few participants had an event.
NA months
Median and corresponding 95% CI could not be estimated as too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Median Time to Overall Survival (OS)
NA months
Median and corresponding 95% CI could not be estimated as too few participants had an event.
NA months
Median and corresponding 95% CI could not be estimated as too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Response Rate (ORR), Investigator-Assessed
Without PET
80.1 percentage of participants
81.4 percentage of participants
Overall Response Rate (ORR), Investigator-Assessed
With PET
77.6 percentage of participants
77.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

Population: The intent-to-treat (ITT) population included all randomized participants.

Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=712 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=706 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Response Rate (ORR), IRC-Assessed
Without PET
80.2 percentage of participants
82.3 percentage of participants
Overall Response Rate (ORR), IRC-Assessed
With PET
81.1 percentage of participants
82.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Complete Response (CR) at the End of Treatment, Investigator-Assessed
Without PET
33.9 percentage of participants
35.4 percentage of participants
Complete Response (CR) at the End of Treatment, Investigator-Assessed
With PET
59.1 percentage of participants
56.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

Population: The intent-to-treat (ITT) population included all randomized participants.

Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=712 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=706 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Complete Response (CR) at the End of Treatment, IRC-Assessed
Without PET
34.4 percentage of participants
39.1 percentage of participants
Complete Response (CR) at the End of Treatment, IRC-Assessed
With PET
65.3 percentage of participants
66.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Median Time to Event-Free Survival (EFS), Investigator-Assessed
74.5 months
The 95% CI could not be estimated as too few participants had an event.
68.3 months
Interval 68.3 to
The upper bound of 95% CI could not be estimated as too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=394 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=417 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Median Time to Disease-Free Survival (DFS), Investigator-Assessed
NA months
Median and corresponding 95% CI could not be estimated as too few participants had an event.
65.4 months
The 95% CI could not be estimated as too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: \>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression \>/= 50%. Progression/relapse: at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 cm or \>/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=641 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=657 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Duration of Response (DOR), Investigator-Assessed
71.9 months
There were not enough events to calculate the confidence intervals.
NA months
Interval 65.4 to
There were not enough events to calculate the median and the upper limit of the confidence interval.

SECONDARY outcome

Timeframe: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)

Population: The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Time to Next Anti-Lymphoma Treatment (TTNALT)
NA months
Interval 74.5 to
Median and upper limit of the 95% confidence interval were not calculable, due to too few participants had an event.
NA months
Median and 95% confidence interval were not calculable, due to too few participants had an event.

SECONDARY outcome

Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Population: The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=701 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=702 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Percentage of Participants With Adverse Events (AEs)
95.3 percentage of participants
98.1 percentage of participants

SECONDARY outcome

Timeframe: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)

Population: The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non- compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=100 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Month 30
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Screening
2.0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Cycle 4 Day 1
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Study Completion / Early Discontinuation
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Month 6
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Month 12
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Month 18
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Month 24
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Follow-Up Completion/ Early Discontinuation
0 percentage of participants
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Unscheduled
0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)

Population: The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=706 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Month 24
7.07 score on a scale
Standard Deviation 10.35
6.66 score on a scale
Standard Deviation 10.50
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Baseline
45.34 score on a scale
Standard Deviation 10.16
45.18 score on a scale
Standard Deviation 9.86
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Cycle 3 Day 1
3.83 score on a scale
Standard Deviation 8.65
3.70 score on a scale
Standard Deviation 9.13
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Study Compl./Discont.
5.03 score on a scale
Standard Deviation 10.21
4.35 score on a scale
Standard Deviation 11.03
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Month 12
6.37 score on a scale
Standard Deviation 10.12
6.18 score on a scale
Standard Deviation 10.51
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Month 30
25.00 score on a scale
Standard Deviation NA
NA = NE = Not estimable based on 1 participant evaluated
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Month 36
7.57 score on a scale
Standard Deviation 10.16
7.31 score on a scale
Standard Deviation 10.67
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Month 48
8.22 score on a scale
Standard Deviation 9.65
7.37 score on a scale
Standard Deviation 10.45
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Score Change, Follow-Up Term./Compl.
5.51 score on a scale
Standard Deviation 10.04
5.55 score on a scale
Standard Deviation 10.62

SECONDARY outcome

Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)

Population: The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=710 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=704 Participants
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Completion
8.74 score on a scale
Standard Deviation 29.40
8.46 score on a scale
Standard Deviation 28.71
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Baseline
59.81 score on a scale
Standard Deviation 24.39
58.55 score on a scale
Standard Deviation 25.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Cycle 3 Day 1
6.37 score on a scale
Standard Deviation 23.77
7.51 score on a scale
Standard Deviation 25.99
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Study Completion
9.84 score on a scale
Standard Deviation 25.96
10.22 score on a scale
Standard Deviation 30.17
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Month 12
12.67 score on a scale
Standard Deviation 26.31
13.84 score on a scale
Standard Deviation 29.97
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Month 24
14.74 score on a scale
Standard Deviation 26.33
15.81 score on a scale
Standard Deviation 29.24
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Month 30
58.33 score on a scale
Standard Deviation NA
NA = NE = Not estimable based on 1 participant evaluated
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Month 36
15.01 score on a scale
Standard Deviation 26.85
17.99 score on a scale
Standard Deviation 28.85
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Change Baseline, Follow-Up Month 48
16.62 score on a scale
Standard Deviation 27.49
17.53 score on a scale
Standard Deviation 30.31

SECONDARY outcome

Timeframe: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)

Population: The Pharmacokinetic assessment was done on a subset of 39 Japanese participants in the Obinutuzumab+Chemotherapy arm only.

Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.

Outcome measures

Outcome measures
Measure
Rituximab+Chemotherapy
n=39 Participants
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 6, Day 1 post-infusion
813 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 32.6
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 8 pre-infusion
174 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 38.7
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 15 pre-infusion
320 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 39.2
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 2, Day 1 pre-infusion
431 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 39.8
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 4, Day 1 pre-infusion
352 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 42.1
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 6, Day 1 pre-infusion
378 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 45.9
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 8, Day 1 pre-infusion
478 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 43.9
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 1 post-infusion
435 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 32.3
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 1 20-28 hours after end of infusion
259 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 56.3
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 1 66-80 hours after end of infusion
219 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 51.2
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 8 post-infusion
578 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 37.8
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 1, Day 15 post-infusion
718 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 32.9
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 2, Day 1 post-infusion
938 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 31.3
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 4, Day 1 post-infusion
817 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 28.6
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Cycle 8, Day 1 post-infusion
881 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 35.9

Adverse Events

Rituximab+Chemotherapy

Serious events: 269 serious events
Other events: 613 other events
Deaths: 0 deaths

Obinutuzumab+Chemotherapy

Serious events: 312 serious events
Other events: 646 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Rituximab+Chemotherapy
n=701 participants at risk
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=702 participants at risk
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Infections and infestations
Nasopharyngitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Necrotising fasciitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Escherichia sepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Fungal infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Gastroenteritis
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
H1N1 influenza
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Hepatitis B Reactivation
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Herpes simplex
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Herpes virus infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Herpes zoster
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.57%
4/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Herpes zoster disseminated
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Infected lymphocele
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Infectious pleural effusion
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Infective glossitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Influenza
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Klebsiella sepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Laryngitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Localised infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Lower respiratory tract infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Lung infection
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.85%
6/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Measles
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Meningitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Meningitis cryptococcal
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Meningitis viral
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Neutropenic infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Neutropenic sepsis
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Oral infection
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Orchitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Osteomyelitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Peritonitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pharyngitis streptococcal
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pneumocystis jirovecii pneumonia
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pneumonia
4.7%
33/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.1%
43/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pneumonia bacterial
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Progressive multifocal leukoencephalopathy
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Prostatic abscess
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pseudomonal sepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Pulmonary sepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Rectal abscess
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Respiratory tract infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Scrotal abscess
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Sepsis
1.4%
10/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
2.3%
16/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Sepsis syndrome
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Septic shock
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.7%
12/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Sinusitis fungal
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Soft tissue infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Subcutaneous abscess
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Tuberculosis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Tuberculosis of central nervous system
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Upper respiratory tract infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Urinary tract infection
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Urosepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Varicella
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Viral infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Viral pharyngitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Wound infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Abdominal wound dehiscence
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Facial bones fracture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Fall
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Femoral neck fracture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Femur fracture
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Fracture
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Hip fracture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Infusion related reaction
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.1%
8/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Kidney rupture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Nerve injury
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Pelvic fracture
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Postoperative respiratory failure
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Procedural complication
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Spinal compression fracture
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Wound haemorrhage
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Investigations
Ejection fraction decreased
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Investigations
HIV antibody positive
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Investigations
Oxygen saturation decreased
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Cachexia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Decreased appetite
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Dehydration
0.57%
4/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.71%
5/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Failure to thrive
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hyperglycaemia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hypokalaemia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hyponatraemia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hypophosphataemia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Malnutrition
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Arthralgia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Back pain
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Costochondritis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Joint swelling
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Amyotrophic lateral sclerosis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Cerebral infarction
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Cerebral ischaemia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Cerebrovascular accident
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Depressed level of consciousness
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Dizziness
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Embolic stroke
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Epilepsy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Headache
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Hemiparesis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Iiird nerve paralysis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Ischaemic stroke
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Loss of consciousness
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Neuropathy peripheral
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Peripheral motor neuropathy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Peripheral sensory neuropathy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Polyneuropathy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Presyncope
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Stroke in evolution
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Syncope
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Toxic encephalopathy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Transient ischaemic attack
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Anxiety
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Completed suicide
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Delirium
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Depression
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Emotional distress
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Mental status changes
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Acute kidney injury
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Cystitis glandularis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Haematuria
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Renal colic
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Renal failure
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Renal impairment
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Renal and urinary disorders
Urinary retention
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Reproductive system and breast disorders
Uterine haemorrhage
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Alveolitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Emphysema
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.86%
6/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.57%
4/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.71%
5/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.57%
4/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.57%
4/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Skin and subcutaneous tissue disorders
Diabetic foot
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Skin and subcutaneous tissue disorders
Skin ulcer
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Deep vein thrombosis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Haemorrhage
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Hypertension
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Hypotension
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Orthostatic hypotension
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Phlebitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Thrombophlebitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Thrombophlebitis superficial
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Venous occlusion
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Venous thrombosis limb
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Bone Marrow Failure
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Anorectal cellulitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmuoblastic T-cell lymphoma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carincoma of pharynx
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Vocal cord paralysis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Axillary vein thrombosis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Jugular vein thrombosis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Subclavian vein thrombosis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Gastrointestinal Infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Seizure
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Anaemia
0.86%
6/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.3%
9/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Febrile neutropenia
10.1%
71/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
12.1%
85/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Haemolytic anaemia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Histiocytosis haematophagic
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Leukopenia
0.86%
6/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
2.0%
14/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Neutropenia
5.4%
38/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
7.7%
54/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Splenic haematoma
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Thrombocytopenia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.7%
12/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Acute coronary syndrome
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Acute myocardial infarction
0.71%
5/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Angina pectoris
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Atrial fibrillation
0.57%
4/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.3%
9/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Atrial flutter
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Bradycardia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiac arrest
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiac failure
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
1.00%
7/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiac failure congestive
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiac perforation
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiomyopathy
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Cardiopulmonary failure
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Congestive cardiomyopathy
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Coronary artery disease
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Coronary artery thrombosis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Hypertensive heart disease
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Mitral valve disease
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Myocardial infarction
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Myocardial ischaemia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Pericardial effusion
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Supraventricular tachycardia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Cardiac disorders
Ventricular flutter
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Ear and labyrinth disorders
Vertigo positional
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Endocrine disorders
Addison's disease
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Endocrine disorders
Goitre
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Eye disorders
Cataract
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Eye disorders
Lacrimation increased
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Abdominal pain
0.86%
6/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.57%
4/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Abdominal pain upper
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Anal fistula
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Colitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Constipation
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Diarrhoea
0.86%
6/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.71%
5/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Dysphagia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastric haemorrhage
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastric perforation
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastritis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastritis haemorrhagic
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Haematemesis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Haematochezia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Ileal perforation
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Ileus
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Ileus paralytic
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Impaired gastric emptying
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Inguinal hernia
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Intestinal ischaemia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Intestinal obstruction
0.71%
5/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Intestinal perforation
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Melaena
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Nausea
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Pneumoperitoneum
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Small intestinal obstruction
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Small intestinal perforation
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Stomatitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Subileus
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Vomiting
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Asthenia
0.57%
4/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Axillary pain
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Chest pain
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Chills
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Death
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Extravasation
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Fatigue
0.71%
5/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.57%
4/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
General physical health deterioration
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Hernia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Hyperpyrexia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Incarcerated hernia
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Malaise
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Mucosal inflammation
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Non-cardiac chest pain
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Oedema peripheral
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Pain
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Peripheral swelling
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Pyrexia
1.6%
11/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
2.4%
17/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Sudden death
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Hepatobiliary disorders
Cholecystitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Hepatobiliary disorders
Cholecystitis acute
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Hepatobiliary disorders
Cholelithiasis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Hepatobiliary disorders
Hepatic function abnormal
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Anal abscess
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Appendiceal abscess
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Appendicitis
0.43%
3/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Atypical pneumonia
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Bacterial infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Bacterial sepsis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Bronchitis
0.57%
4/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Bronchopulmonary aspergillosis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Candida sepsis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Cellulitis
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Cholecystitis infective
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Clostridium difficile colitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Clostridium difficile infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Cytomegalovirus chorioretinitis
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.43%
3/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Cytomegalovirus colitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Cytomegalovirus infection
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Device related infection
0.29%
2/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Device related sepsis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Diabetic foot infection
0.14%
1/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.00%
0/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Diarrhoea infectious
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.28%
2/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Diverticulitis
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Enterobacter infection
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Enterocolitis infectious
0.00%
0/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
0.14%
1/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Other adverse events

Other adverse events
Measure
Rituximab+Chemotherapy
n=701 participants at risk
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Obinutuzumab+Chemotherapy
n=702 participants at risk
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Blood and lymphatic system disorders
Anaemia
14.4%
101/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
13.7%
96/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Febrile neutropenia
6.3%
44/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
7.4%
52/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Leukopenia
12.8%
90/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
16.7%
117/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Neutropenia
38.4%
269/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
44.9%
315/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Blood and lymphatic system disorders
Thrombocytopenia
2.3%
16/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
8.3%
58/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Abdominal pain
6.7%
47/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.7%
47/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Abdominal pain upper
5.8%
41/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
5.4%
38/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Constipation
25.2%
177/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
23.8%
167/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Diarrhoea
13.0%
91/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
16.1%
113/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Dyspepsia
6.1%
43/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.3%
44/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Nausea
28.4%
199/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
29.9%
210/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Stomatitis
9.3%
65/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.7%
47/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Gastrointestinal disorders
Vomiting
10.7%
75/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
15.0%
105/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Asthenia
10.6%
74/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
10.8%
76/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Chills
5.3%
37/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
18.8%
132/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Fatigue
17.7%
124/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
19.4%
136/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Mucosal inflammation
5.1%
36/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.4%
45/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Oedema peripheral
5.7%
40/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
5.0%
35/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
General disorders
Pyrexia
10.7%
75/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
19.5%
137/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Infections and infestations
Upper respiratory tract infection
7.0%
49/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.1%
43/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Injury, poisoning and procedural complications
Infusion related reaction
23.1%
162/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
35.8%
251/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Decreased appetite
10.6%
74/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
14.0%
98/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Metabolism and nutrition disorders
Hypokalaemia
7.8%
55/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
9.5%
67/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Back pain
5.8%
41/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
8.3%
58/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Dizziness
4.1%
29/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.8%
48/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Dysgeusia
5.4%
38/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.3%
44/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Headache
8.3%
58/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
10.7%
75/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Neuropathy peripheral
12.6%
88/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
12.4%
87/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Paraesthesia
7.1%
50/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
7.8%
55/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Nervous system disorders
Peripheral sensory neuropathy
8.1%
57/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
7.7%
54/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Psychiatric disorders
Insomnia
8.7%
61/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
11.3%
79/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Cough
9.4%
66/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
12.5%
88/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.4%
31/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
7.4%
52/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
5.4%
38/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
6.1%
43/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Skin and subcutaneous tissue disorders
Alopecia
20.5%
144/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
21.1%
148/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Skin and subcutaneous tissue disorders
Rash
6.4%
45/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
2.4%
17/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Vascular disorders
Hypertension
3.9%
27/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
5.7%
40/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Investigations
Alanine Aminotransferase Increased
4.1%
29/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
5.6%
39/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
Musculoskeletal and connective tissue disorders
Arthralgia
4.0%
28/701 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
5.3%
37/702 • 6 years and 7 months
The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.

Additional Information

Medical Communications

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Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER