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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287741
Recruitment Status : Terminated (The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.)
First Posted : February 1, 2011
Results First Posted : August 17, 2017
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-Cell Lymphoma
Interventions Drug: Rituximab
Drug: Obinutuzumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Enrollment 1418
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 712 706
Completed 86 91
Not Completed 626 615
Reason Not Completed
Withdrawal by Subject             35             38
Protocol Violation             2             0
Physician Decision             15             23
Non-compliance             8             6
Lost to Follow-up             10             8
Death             32             44
Adverse Event             4             6
Study terminated by Sponsor             307             315
Progressive disease             190             166
Reason not specified             23             9
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 710 704 1414
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants. However, 4 patients were classified as misconduct patients and were not included in the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 710 participants 704 participants 1414 participants
59.1  (13.6) 59.4  (13.3) 59.2  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 710 participants 704 participants 1414 participants
Female
328
  46.2%
336
  47.7%
664
  47.0%
Male
382
  53.8%
368
  52.3%
750
  53.0%
1.Primary Outcome
Title Median Time to Progression-Free Survival (PFS), Investigator-Assessed
Hide Description 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).
Time Frame Baseline up to approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Median (95% Confidence Interval)
Unit of Measure: months
74.5 [1] 
(NA to NA)
68.3 [2] 
(68.3 to NA)
[1]
The 95% CI could not be estimated as too few participants had an event.
[2]
Upper bound of 95% CI could not be estimated as too few participants had an event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4753
Comments [Not Specified]
Method Log Rank
Comments Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.78 to 1.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
Hide Description 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.
Time Frame Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 712 706
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated as too few participants had an event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2736
Comments [Not Specified]
Method Log Rank
Comments Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.72 to 1.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Median Time to Overall Survival (OS)
Hide Description 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.
Time Frame Baseline up to approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated as too few participants had an event.
4.Secondary Outcome
Title Overall Response Rate (ORR), Investigator-Assessed
Hide Description 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.
Time Frame Baseline up to approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Measure Type: Number
Unit of Measure: percentage of participants
Without PET Number Analyzed 710 participants 704 participants
80.1 81.4
With PET Number Analyzed 665 participants 669 participants
77.6 77.1
5.Secondary Outcome
Title Overall Response Rate (ORR), IRC-Assessed
Hide Description 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.
Time Frame Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET Number Analyzed 712 participants 706 participants
80.2 82.3
With PET Number Analyzed 665 participants 669 participants
81.1 82.1
6.Secondary Outcome
Title Complete Response (CR) at the End of Treatment, Investigator-Assessed
Hide Description 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.
Time Frame Baseline up to approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Measure Type: Number
Unit of Measure: percentage of participants
Without PET Number Analyzed 710 participants 704 participants
33.9 35.4
With PET Number Analyzed 665 participants 669 participants
59.1 56.5
7.Secondary Outcome
Title Complete Response (CR) at the End of Treatment, IRC-Assessed
Hide Description 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.
Time Frame Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET Number Analyzed 712 participants 706 participants
34.4 39.1
With PET Number Analyzed 665 participants 669 participants
65.3 66.7
8.Secondary Outcome
Title Median Time to Event-Free Survival (EFS), Investigator-Assessed
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Mean (95% Confidence Interval)
Unit of Measure: months
74.5 [1] 
(NA to NA)
68.3 [2] 
(68.3 to NA)
[1]
The 95% CI could not be estimated as too few participants had an event.
[2]
The upper bound of 95% CI could not be estimated as too few participants had an event.
9.Secondary Outcome
Title Median Time to Disease-Free Survival (DFS), Investigator-Assessed
Hide Description 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.
Time Frame Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 394 417
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
65.4 [2] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated as too few participants had an event.
[2]
The 95% CI could not be estimated as too few participants had an event.
10.Secondary Outcome
Title Duration of Response (DOR), Investigator-Assessed
Hide Description 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%.
Time Frame Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 641 657
Median (95% Confidence Interval)
Unit of Measure: months
71.9 [1] 
(NA to NA)
NA [2] 
(65.4 to NA)
[1]
There were not enough events to calculate the confidence intervals.
[2]
There were not enough events to calculate the median and the upper limit of the confidence interval.
11.Secondary Outcome
Title Time to Next Anti-Lymphoma Treatment (TTNALT)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(74.5 to NA)
NA [2] 
(NA to NA)
[1]
Median and upper limit of the 95% confidence interval were not calculable, due to too few participants had an event.
[2]
Median and 95% confidence interval were not calculable, due to too few participants had an event.
12.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Baseline up to approximately 6.5 years (up to 31 January 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 701 702
Measure Type: Number
Unit of Measure: percentage of participants
95.3 98.1
13.Secondary Outcome
Title Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Hide Description The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
Screening Number Analyzed 100 participants
2.0
Cycle 4 Day 1 Number Analyzed 86 participants
0
Study Completion / Early Discontinuation Number Analyzed 65 participants
0
Follow-Up Month 6 Number Analyzed 40 participants
0
Follow-Up Month 12 Number Analyzed 40 participants
0
Follow-Up Month 18 Number Analyzed 27 participants
0
Follow-Up Month 24 Number Analyzed 25 participants
0
Follow-Up Month 30 Number Analyzed 19 participants
0
Follow-Up Completion/ Early Discontinuation Number Analyzed 46 participants
0
Unscheduled Number Analyzed 3 participants
0
14.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Hide Description 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.
Time Frame 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)
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Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 706
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 609 participants 639 participants
45.34  (10.16) 45.18  (9.86)
Score Change, Cycle 3 Day 1 Number Analyzed 553 participants 563 participants
3.83  (8.65) 3.70  (9.13)
Score Change, Study Compl./Discont. Number Analyzed 526 participants 527 participants
5.03  (10.21) 4.35  (11.03)
Score Change, Follow-Up Month 12 Number Analyzed 371 participants 411 participants
6.37  (10.12) 6.18  (10.51)
Score Change, Follow-Up Month 24 Number Analyzed 335 participants 372 participants
7.07  (10.35) 6.66  (10.50)
Score Change, Follow-Up Month 30 Number Analyzed 0 participants 1 participants
25.00 [1]   (NA)
Score Change, Follow-Up Month 36 Number Analyzed 317 participants 353 participants
7.57  (10.16) 7.31  (10.67)
Score Change, Follow-Up Month 48 Number Analyzed 167 participants 192 participants
8.22  (9.65) 7.37  (10.45)
Score Change, Follow-Up Term./Compl. Number Analyzed 121 participants 135 participants
5.51  (10.04) 5.55  (10.62)
[1]
NA = NE = Not estimable based on 1 participant evaluated
15.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Hide Description 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.
Time Frame 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)
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Hide Analysis Population Description
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.
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 710 704
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 610 participants 641 participants
59.81  (24.39) 58.55  (25.23)
Change Baseline, Cycle 1 Day 1 Number Analyzed 0 participants 0 participants
Change Baseline, Cycle 3 Day 1 Number Analyzed 556 participants 565 participants
6.37  (23.77) 7.51  (25.99)
Change Baseline, Study Completion Number Analyzed 526 participants 530 participants
9.84  (25.96) 10.22  (30.17)
Change Baseline, Follow-Up Month 12 Number Analyzed 371 participants 413 participants
12.67  (26.31) 13.84  (29.97)
Change Baseline, Follow-Up Month 24 Number Analyzed 337 participants 370 participants
14.74  (26.33) 15.81  (29.24)
Change Baseline, Follow-Up Month 30 Number Analyzed 0 participants 1 participants
58.33 [1]   (NA)
Change Baseline, Follow-Up Month 36 Number Analyzed 321 participants 352 participants
15.01  (26.85) 17.99  (28.85)
Change Baseline, Follow-Up Month 48 Number Analyzed 168 participants 193 participants
16.62  (27.49) 17.53  (30.31)
Change Baseline, Follow-Up Completion Number Analyzed 122 participants 136 participants
8.74  (29.40) 8.46  (28.71)
[1]
NA = NE = Not estimable based on 1 participant evaluated
16.Secondary Outcome
Title Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Hide Description Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
Time Frame 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)
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Hide Analysis Population Description
The Pharmacokinetic assessment was done on a subset of 39 Japanese participants in the Obinutuzumab+Chemotherapy arm only.
Arm/Group Title Obinutuzumab+Chemotherapy
Hide Arm/Group Description:
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 Number of Participants Analyzed 39
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (μg/mL)
Cycle 1, Day 8 pre-infusion
174
(38.7%)
Cycle 1, Day 15 pre-infusion
320
(39.2%)
Cycle 2, Day 1 pre-infusion
431
(39.8%)
Cycle 4, Day 1 pre-infusion
352
(42.1%)
Cycle 6, Day 1 pre-infusion
378
(45.9%)
Cycle 8, Day 1 pre-infusion
478
(43.9%)
Cycle 1, Day 1 post-infusion
435
(32.3%)
Cycle 1, Day 1 20-28 hours after end of infusion
259
(56.3%)
Cycle 1, Day 1 66-80 hours after end of infusion
219
(51.2%)
Cycle 1, Day 8 post-infusion
578
(37.8%)
Cycle 1, Day 15 post-infusion
718
(32.9%)
Cycle 2, Day 1 post-infusion
938
(31.3%)
Cycle 4, Day 1 post-infusion
817
(28.6%)
Cycle 6, Day 1 post-infusion
813
(32.6%)
Cycle 8, Day 1 post-infusion
881
(35.9%)
Time Frame 6 years and 7 months
Adverse Event Reporting Description The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP). Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 patients enrolled at the site (2 in each treatment arm) were excluded from the final analysis.
 
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   269/701 (38.37%)   312/702 (44.44%) 
Blood and lymphatic system disorders     
Anaemia  1  6/701 (0.86%)  9/702 (1.28%) 
Febrile neutropenia  1  71/701 (10.13%)  85/702 (12.11%) 
Haemolytic anaemia  1  1/701 (0.14%)  0/702 (0.00%) 
Histiocytosis haematophagic  1  0/701 (0.00%)  1/702 (0.14%) 
Immune thrombocytopenic purpura  1  0/701 (0.00%)  1/702 (0.14%) 
Leukopenia  1  6/701 (0.86%)  14/702 (1.99%) 
Neutropenia  1  38/701 (5.42%)  54/702 (7.69%) 
Splenic haematoma  1  0/701 (0.00%)  1/702 (0.14%) 
Thrombocytopenia  1  2/701 (0.29%)  12/702 (1.71%) 
Bone Marrow Failure  1  1/701 (0.14%)  0/702 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  0/701 (0.00%)  1/702 (0.14%) 
Acute myocardial infarction  1  5/701 (0.71%)  2/702 (0.28%) 
Angina pectoris  1  2/701 (0.29%)  0/702 (0.00%) 
Atrial fibrillation  1  4/701 (0.57%)  9/702 (1.28%) 
Atrial flutter  1  1/701 (0.14%)  1/702 (0.14%) 
Bradycardia  1  0/701 (0.00%)  1/702 (0.14%) 
Cardiac arrest  1  1/701 (0.14%)  1/702 (0.14%) 
Cardiac failure  1  3/701 (0.43%)  7/702 (1.00%) 
Cardiac failure congestive  1  1/701 (0.14%)  3/702 (0.43%) 
Cardiac perforation  1  0/701 (0.00%)  1/702 (0.14%) 
Cardiomyopathy  1  0/701 (0.00%)  1/702 (0.14%) 
Cardiopulmonary failure  1  1/701 (0.14%)  0/702 (0.00%) 
Congestive cardiomyopathy  1  1/701 (0.14%)  0/702 (0.00%) 
Coronary artery disease  1  1/701 (0.14%)  0/702 (0.00%) 
Coronary artery thrombosis  1  0/701 (0.00%)  1/702 (0.14%) 
Hypertensive heart disease  1  0/701 (0.00%)  1/702 (0.14%) 
Left ventricular dysfunction  1  0/701 (0.00%)  1/702 (0.14%) 
Mitral valve disease  1  0/701 (0.00%)  1/702 (0.14%) 
Myocardial infarction  1  2/701 (0.29%)  3/702 (0.43%) 
Myocardial ischaemia  1  1/701 (0.14%)  0/702 (0.00%) 
Pericardial effusion  1  0/701 (0.00%)  1/702 (0.14%) 
Supraventricular tachycardia  1  1/701 (0.14%)  0/702 (0.00%) 
Ventricular flutter  1  0/701 (0.00%)  1/702 (0.14%) 
Ear and labyrinth disorders     
Vertigo positional  1  0/701 (0.00%)  1/702 (0.14%) 
Endocrine disorders     
Addison's disease  1  0/701 (0.00%)  1/702 (0.14%) 
Goitre  1  1/701 (0.14%)  0/702 (0.00%) 
Eye disorders     
Cataract  1  2/701 (0.29%)  0/702 (0.00%) 
Lacrimation increased  1  0/701 (0.00%)  1/702 (0.14%) 
Gastrointestinal disorders     
Abdominal pain  1  6/701 (0.86%)  4/702 (0.57%) 
Abdominal pain upper  1  1/701 (0.14%)  2/702 (0.28%) 
Anal fistula  1  1/701 (0.14%)  0/702 (0.00%) 
Colitis  1  2/701 (0.29%)  2/702 (0.28%) 
Constipation  1  1/701 (0.14%)  0/702 (0.00%) 
Diarrhoea  1  6/701 (0.86%)  5/702 (0.71%) 
Dysphagia  1  0/701 (0.00%)  1/702 (0.14%) 
Gastric haemorrhage  1  2/701 (0.29%)  1/702 (0.14%) 
Gastric perforation  1  3/701 (0.43%)  1/702 (0.14%) 
Gastric ulcer  1  0/701 (0.00%)  1/702 (0.14%) 
Gastritis  1  0/701 (0.00%)  1/702 (0.14%) 
Gastritis haemorrhagic  1  0/701 (0.00%)  1/702 (0.14%) 
Gastrointestinal haemorrhage  1  3/701 (0.43%)  2/702 (0.28%) 
Haematemesis  1  0/701 (0.00%)  1/702 (0.14%) 
Haematochezia  1  1/701 (0.14%)  0/702 (0.00%) 
Haemorrhoids  1  0/701 (0.00%)  2/702 (0.28%) 
Ileal perforation  1  0/701 (0.00%)  1/702 (0.14%) 
Ileus  1  2/701 (0.29%)  1/702 (0.14%) 
Ileus paralytic  1  1/701 (0.14%)  0/702 (0.00%) 
Impaired gastric emptying  1  1/701 (0.14%)  0/702 (0.00%) 
Inguinal hernia  1  1/701 (0.14%)  1/702 (0.14%) 
Intestinal ischaemia  1  0/701 (0.00%)  1/702 (0.14%) 
Intestinal obstruction  1  5/701 (0.71%)  2/702 (0.28%) 
Intestinal perforation  1  3/701 (0.43%)  3/702 (0.43%) 
Large intestine polyp  1  0/701 (0.00%)  2/702 (0.28%) 
Lower gastrointestinal haemorrhage  1  1/701 (0.14%)  0/702 (0.00%) 
Melaena  1  1/701 (0.14%)  0/702 (0.00%) 
Nausea  1  2/701 (0.29%)  1/702 (0.14%) 
Pancreatitis acute  1  0/701 (0.00%)  1/702 (0.14%) 
Pneumoperitoneum  1  0/701 (0.00%)  1/702 (0.14%) 
Small intestinal obstruction  1  1/701 (0.14%)  2/702 (0.28%) 
Small intestinal perforation  1  1/701 (0.14%)  1/702 (0.14%) 
Stomatitis  1  1/701 (0.14%)  0/702 (0.00%) 
Subileus  1  1/701 (0.14%)  1/702 (0.14%) 
Upper gastrointestinal haemorrhage  1  1/701 (0.14%)  3/702 (0.43%) 
Vomiting  1  2/701 (0.29%)  2/702 (0.28%) 
General disorders     
Asthenia  1  4/701 (0.57%)  2/702 (0.28%) 
Axillary pain  1  0/701 (0.00%)  1/702 (0.14%) 
Chest pain  1  2/701 (0.29%)  0/702 (0.00%) 
Chills  1  1/701 (0.14%)  2/702 (0.28%) 
Death  1  2/701 (0.29%)  3/702 (0.43%) 
Extravasation  1  1/701 (0.14%)  0/702 (0.00%) 
Fatigue  1  5/701 (0.71%)  4/702 (0.57%) 
General physical health deterioration  1  1/701 (0.14%)  2/702 (0.28%) 
Hernia  1  0/701 (0.00%)  1/702 (0.14%) 
Hyperpyrexia  1  0/701 (0.00%)  1/702 (0.14%) 
Incarcerated hernia  1  0/701 (0.00%)  1/702 (0.14%) 
Malaise  1  0/701 (0.00%)  2/702 (0.28%) 
Mucosal inflammation  1  1/701 (0.14%)  1/702 (0.14%) 
Non-cardiac chest pain  1  2/701 (0.29%)  0/702 (0.00%) 
Oedema peripheral  1  0/701 (0.00%)  2/702 (0.28%) 
Pain  1  1/701 (0.14%)  0/702 (0.00%) 
Peripheral swelling  1  1/701 (0.14%)  0/702 (0.00%) 
Pyrexia  1  11/701 (1.57%)  17/702 (2.42%) 
Sudden death  1  1/701 (0.14%)  1/702 (0.14%) 
Hepatobiliary disorders     
Bile duct obstruction  1  0/701 (0.00%)  1/702 (0.14%) 
Cholecystitis  1  2/701 (0.29%)  1/702 (0.14%) 
Cholecystitis acute  1  1/701 (0.14%)  1/702 (0.14%) 
Cholelithiasis  1  1/701 (0.14%)  0/702 (0.00%) 
Hepatic function abnormal  1  1/701 (0.14%)  0/702 (0.00%) 
Infections and infestations     
Anal abscess  1  0/701 (0.00%)  2/702 (0.28%) 
Appendiceal abscess  1  0/701 (0.00%)  1/702 (0.14%) 
Appendicitis  1  3/701 (0.43%)  1/702 (0.14%) 
Atypical pneumonia  1  2/701 (0.29%)  0/702 (0.00%) 
Bacterial infection  1  1/701 (0.14%)  0/702 (0.00%) 
Bacterial sepsis  1  0/701 (0.00%)  1/702 (0.14%) 
Bronchitis  1  4/701 (0.57%)  1/702 (0.14%) 
Bronchopulmonary aspergillosis  1  1/701 (0.14%)  1/702 (0.14%) 
Candida sepsis  1  1/701 (0.14%)  0/702 (0.00%) 
Cellulitis  1  2/701 (0.29%)  2/702 (0.28%) 
Cholecystitis infective  1  0/701 (0.00%)  1/702 (0.14%) 
Clostridium difficile colitis  1  1/701 (0.14%)  1/702 (0.14%) 
Clostridium difficile infection  1  0/701 (0.00%)  1/702 (0.14%) 
Cytomegalovirus chorioretinitis  1  1/701 (0.14%)  3/702 (0.43%) 
Cytomegalovirus colitis  1  0/701 (0.00%)  1/702 (0.14%) 
Cytomegalovirus infection  1  2/701 (0.29%)  0/702 (0.00%) 
Device related infection  1  2/701 (0.29%)  1/702 (0.14%) 
Device related sepsis  1  0/701 (0.00%)  1/702 (0.14%) 
Diabetic foot infection  1  1/701 (0.14%)  0/702 (0.00%) 
Diarrhoea infectious  1  0/701 (0.00%)  2/702 (0.28%) 
Diverticulitis  1  0/701 (0.00%)  1/702 (0.14%) 
Enterobacter infection  1  0/701 (0.00%)  1/702 (0.14%) 
Enterocolitis infectious  1  0/701 (0.00%)  1/702 (0.14%) 
Escherichia sepsis  1  1/701 (0.14%)  0/702 (0.00%) 
Fungal infection  1  1/701 (0.14%)  0/702 (0.00%) 
Gastroenteritis  1  3/701 (0.43%)  2/702 (0.28%) 
H1N1 influenza  1  0/701 (0.00%)  1/702 (0.14%) 
Hepatitis B Reactivation  1  0/701 (0.00%)  1/702 (0.14%) 
Herpes simplex  1  0/701 (0.00%)  1/702 (0.14%) 
Herpes virus infection  1  0/701 (0.00%)  2/702 (0.28%) 
Herpes zoster  1  3/701 (0.43%)  4/702 (0.57%) 
Herpes zoster disseminated  1  0/701 (0.00%)  1/702 (0.14%) 
Infected lymphocele  1  0/701 (0.00%)  1/702 (0.14%) 
Infection  1  0/701 (0.00%)  2/702 (0.28%) 
Infectious pleural effusion  1  0/701 (0.00%)  2/702 (0.28%) 
Infective glossitis  1  0/701 (0.00%)  1/702 (0.14%) 
Influenza  1  2/701 (0.29%)  1/702 (0.14%) 
Klebsiella sepsis  1  1/701 (0.14%)  1/702 (0.14%) 
Laryngitis  1  0/701 (0.00%)  1/702 (0.14%) 
Localised infection  1  1/701 (0.14%)  0/702 (0.00%) 
Lower respiratory tract infection  1  1/701 (0.14%)  3/702 (0.43%) 
Lung infection  1  3/701 (0.43%)  6/702 (0.85%) 
Measles  1  0/701 (0.00%)  1/702 (0.14%) 
Meningitis  1  0/701 (0.00%)  1/702 (0.14%) 
Meningitis cryptococcal  1  1/701 (0.14%)  0/702 (0.00%) 
Meningitis viral  1  0/701 (0.00%)  1/702 (0.14%) 
Nasopharyngitis  1  2/701 (0.29%)  0/702 (0.00%) 
Necrotising fasciitis  1  1/701 (0.14%)  0/702 (0.00%) 
Neutropenic infection  1  1/701 (0.14%)  1/702 (0.14%) 
Neutropenic sepsis  1  3/701 (0.43%)  3/702 (0.43%) 
Oral infection  1  2/701 (0.29%)  0/702 (0.00%) 
Orchitis  1  1/701 (0.14%)  0/702 (0.00%) 
Osteomyelitis  1  1/701 (0.14%)  1/702 (0.14%) 
Peritonitis  1  2/701 (0.29%)  2/702 (0.28%) 
Pharyngitis streptococcal  1  0/701 (0.00%)  1/702 (0.14%) 
Pneumocystis jirovecii pneumonia  1  3/701 (0.43%)  1/702 (0.14%) 
Pneumonia  1  33/701 (4.71%)  43/702 (6.13%) 
Pneumonia bacterial  1  0/701 (0.00%)  1/702 (0.14%) 
Progressive multifocal leukoencephalopathy  1  0/701 (0.00%)  1/702 (0.14%) 
Prostatic abscess  1  1/701 (0.14%)  0/702 (0.00%) 
Pseudomonal sepsis  1  1/701 (0.14%)  0/702 (0.00%) 
Pulmonary sepsis  1  1/701 (0.14%)  0/702 (0.00%) 
Rectal abscess  1  1/701 (0.14%)  1/702 (0.14%) 
Respiratory tract infection  1  0/701 (0.00%)  2/702 (0.28%) 
Scrotal abscess  1  1/701 (0.14%)  0/702 (0.00%) 
Sepsis  1  10/701 (1.43%)  16/702 (2.28%) 
Sepsis syndrome  1  0/701 (0.00%)  1/702 (0.14%) 
Septic shock  1  3/701 (0.43%)  12/702 (1.71%) 
Sinusitis fungal  1  0/701 (0.00%)  1/702 (0.14%) 
Soft tissue infection  1  1/701 (0.14%)  0/702 (0.00%) 
Subcutaneous abscess  1  0/701 (0.00%)  1/702 (0.14%) 
Tuberculosis  1  1/701 (0.14%)  0/702 (0.00%) 
Tuberculosis of central nervous system  1  1/701 (0.14%)  0/702 (0.00%) 
Upper respiratory tract infection  1  1/701 (0.14%)  1/702 (0.14%) 
Urinary tract infection  1  3/701 (0.43%)  3/702 (0.43%) 
Urosepsis  1  1/701 (0.14%)  1/702 (0.14%) 
Varicella  1  1/701 (0.14%)  1/702 (0.14%) 
Viral infection  1  0/701 (0.00%)  1/702 (0.14%) 
Viral pharyngitis  1  1/701 (0.14%)  0/702 (0.00%) 
Wound infection  1  0/701 (0.00%)  1/702 (0.14%) 
Anorectal cellulitis  1  1/701 (0.14%)  0/702 (0.00%) 
Gastrointestinal Infection  1  1/701 (0.14%)  0/702 (0.00%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence  1  1/701 (0.14%)  0/702 (0.00%) 
Facial bones fracture  1  1/701 (0.14%)  0/702 (0.00%) 
Fall  1  0/701 (0.00%)  1/702 (0.14%) 
Femoral neck fracture  1  1/701 (0.14%)  0/702 (0.00%) 
Femur fracture  1  2/701 (0.29%)  1/702 (0.14%) 
Fracture  1  0/701 (0.00%)  1/702 (0.14%) 
Hip fracture  1  1/701 (0.14%)  1/702 (0.14%) 
Infusion related reaction  1  1/701 (0.14%)  8/702 (1.14%) 
Kidney rupture  1  1/701 (0.14%)  0/702 (0.00%) 
Lumbar vertebral fracture  1  1/701 (0.14%)  0/702 (0.00%) 
Nerve injury  1  0/701 (0.00%)  1/702 (0.14%) 
Pelvic fracture  1  0/701 (0.00%)  1/702 (0.14%) 
Postoperative respiratory failure  1  0/701 (0.00%)  1/702 (0.14%) 
Procedural complication  1  0/701 (0.00%)  1/702 (0.14%) 
Spinal compression fracture  1  1/701 (0.14%)  0/702 (0.00%) 
Subdural haematoma  1  0/701 (0.00%)  3/702 (0.43%) 
Toxicity to various agents  1  0/701 (0.00%)  1/702 (0.14%) 
Vascular pseudoaneurysm  1  1/701 (0.14%)  0/702 (0.00%) 
Wound haemorrhage  1  0/701 (0.00%)  1/702 (0.14%) 
Compression fracture  1  0/701 (0.00%)  1/702 (0.14%) 
Investigations     
Ejection fraction decreased  1  0/701 (0.00%)  1/702 (0.14%) 
HIV antibody positive  1  0/701 (0.00%)  1/702 (0.14%) 
Oxygen saturation decreased  1  1/701 (0.14%)  0/702 (0.00%) 
Metabolism and nutrition disorders     
Cachexia  1  0/701 (0.00%)  1/702 (0.14%) 
Decreased appetite  1  1/701 (0.14%)  2/702 (0.28%) 
Dehydration  1  4/701 (0.57%)  5/702 (0.71%) 
Diabetes mellitus  1  0/701 (0.00%)  1/702 (0.14%) 
Failure to thrive  1  3/701 (0.43%)  0/702 (0.00%) 
Hyperglycaemia  1  1/701 (0.14%)  0/702 (0.00%) 
Hyperkalaemia  1  0/701 (0.00%)  1/702 (0.14%) 
Hypokalaemia  1  2/701 (0.29%)  2/702 (0.28%) 
Hyponatraemia  1  2/701 (0.29%)  0/702 (0.00%) 
Hypophosphataemia  1  1/701 (0.14%)  0/702 (0.00%) 
Malnutrition  1  2/701 (0.29%)  1/702 (0.14%) 
Tumour lysis syndrome  1  2/701 (0.29%)  1/702 (0.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/701 (0.29%)  1/702 (0.14%) 
Back pain  1  1/701 (0.14%)  2/702 (0.28%) 
Costochondritis  1  1/701 (0.14%)  0/702 (0.00%) 
Intervertebral disc protrusion  1  0/701 (0.00%)  1/702 (0.14%) 
Joint swelling  1  1/701 (0.14%)  0/702 (0.00%) 
Myalgia  1  0/701 (0.00%)  1/702 (0.14%) 
Osteoarthritis  1  0/701 (0.00%)  1/702 (0.14%) 
Pain in extremity  1  1/701 (0.14%)  0/702 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  2/701 (0.29%)  1/702 (0.14%) 
Adenocarcinoma of colon  1  2/701 (0.29%)  0/702 (0.00%) 
B-cell lymphoma  1  1/701 (0.14%)  0/702 (0.00%) 
Breast cancer  1  3/701 (0.43%)  1/702 (0.14%) 
Colon adenoma  1  0/701 (0.00%)  1/702 (0.14%) 
Colon cancer  1  2/701 (0.29%)  0/702 (0.00%) 
Colorectal cancer  1  1/701 (0.14%)  1/702 (0.14%) 
Hepatocellular carcinoma  1  1/701 (0.14%)  2/702 (0.28%) 
Liposarcoma  1  0/701 (0.00%)  1/702 (0.14%) 
Lung adenocarcinoma  1  2/701 (0.29%)  3/702 (0.43%) 
Marginal zone lymphoma  1  1/701 (0.14%)  0/702 (0.00%) 
Oesophageal carcinoma  1  1/701 (0.14%)  0/702 (0.00%) 
Papillary cystadenoma lymphomatosum  1  0/701 (0.00%)  1/702 (0.14%) 
Prostate cancer  1  2/701 (0.29%)  2/702 (0.28%) 
Small cell lung cancer metastatic  1  0/701 (0.00%)  1/702 (0.14%) 
Tumour perforation  1  0/701 (0.00%)  1/702 (0.14%) 
Angioimmuoblastic T-cell lymphoma  1  0/701 (0.00%)  1/702 (0.14%) 
Myelodysplastic syndrome  1  0/701 (0.00%)  1/702 (0.14%) 
Squamous cell carincoma of pharynx  1  1/701 (0.14%)  0/702 (0.00%) 
Lung neoplasm malignant  1  0/701 (0.00%)  1/702 (0.14%) 
Plasma cell myeloma  1  1/701 (0.14%)  0/702 (0.00%) 
Nervous system disorders     
Amyotrophic lateral sclerosis  1  0/701 (0.00%)  1/702 (0.14%) 
Cerebral haemorrhage  1  0/701 (0.00%)  1/702 (0.14%) 
Cerebral infarction  1  1/701 (0.14%)  0/702 (0.00%) 
Cerebral ischaemia  1  1/701 (0.14%)  1/702 (0.14%) 
Cerebrovascular accident  1  2/701 (0.29%)  3/702 (0.43%) 
Depressed level of consciousness  1  0/701 (0.00%)  1/702 (0.14%) 
Dizziness  1  0/701 (0.00%)  2/702 (0.28%) 
Embolic stroke  1  1/701 (0.14%)  0/702 (0.00%) 
Epilepsy  1  1/701 (0.14%)  0/702 (0.00%) 
Headache  1  2/701 (0.29%)  3/702 (0.43%) 
Hemiparesis  1  0/701 (0.00%)  1/702 (0.14%) 
Iiird nerve paralysis  1  0/701 (0.00%)  1/702 (0.14%) 
Ischaemic stroke  1  0/701 (0.00%)  1/702 (0.14%) 
Loss of consciousness  1  1/701 (0.14%)  0/702 (0.00%) 
Neuropathy peripheral  1  1/701 (0.14%)  1/702 (0.14%) 
Peripheral motor neuropathy  1  1/701 (0.14%)  0/702 (0.00%) 
Peripheral sensory neuropathy  1  1/701 (0.14%)  0/702 (0.00%) 
Polyneuropathy  1  1/701 (0.14%)  0/702 (0.00%) 
Presyncope  1  1/701 (0.14%)  2/702 (0.28%) 
Stroke in evolution  1  0/701 (0.00%)  1/702 (0.14%) 
Syncope  1  3/701 (0.43%)  0/702 (0.00%) 
Toxic encephalopathy  1  1/701 (0.14%)  0/702 (0.00%) 
Transient ischaemic attack  1  1/701 (0.14%)  0/702 (0.00%) 
Vocal cord paralysis  1  1/701 (0.14%)  0/702 (0.00%) 
Seizure  1  0/701 (0.00%)  1/702 (0.14%) 
Psychiatric disorders     
Anxiety  1  0/701 (0.00%)  1/702 (0.14%) 
Completed suicide  1  0/701 (0.00%)  1/702 (0.14%) 
Delirium  1  0/701 (0.00%)  1/702 (0.14%) 
Depression  1  1/701 (0.14%)  0/702 (0.00%) 
Emotional distress  1  0/701 (0.00%)  1/702 (0.14%) 
Mental status changes  1  0/701 (0.00%)  1/702 (0.14%) 
Renal and urinary disorders     
Acute kidney injury  1  2/701 (0.29%)  2/702 (0.28%) 
Cystitis glandularis  1  0/701 (0.00%)  1/702 (0.14%) 
Haematuria  1  0/701 (0.00%)  2/702 (0.28%) 
Renal colic  1  1/701 (0.14%)  0/702 (0.00%) 
Renal failure  1  1/701 (0.14%)  1/702 (0.14%) 
Renal impairment  1  0/701 (0.00%)  1/702 (0.14%) 
Urinary retention  1  0/701 (0.00%)  1/702 (0.14%) 
Reproductive system and breast disorders     
Uterine haemorrhage  1  0/701 (0.00%)  1/702 (0.14%) 
Respiratory, thoracic and mediastinal disorders     
Acquired tracheo-oesophageal fistula  1  0/701 (0.00%)  1/702 (0.14%) 
Acute pulmonary oedema  1  0/701 (0.00%)  1/702 (0.14%) 
Acute respiratory distress syndrome  1  1/701 (0.14%)  1/702 (0.14%) 
Acute respiratory failure  1  3/701 (0.43%)  1/702 (0.14%) 
Alveolitis  1  0/701 (0.00%)  1/702 (0.14%) 
Asthma  1  0/701 (0.00%)  1/702 (0.14%) 
Bronchial obstruction  1  1/701 (0.14%)  0/702 (0.00%) 
Bronchospasm  1  1/701 (0.14%)  1/702 (0.14%) 
Chronic obstructive pulmonary disease  1  1/701 (0.14%)  2/702 (0.28%) 
Dyspnoea  1  1/701 (0.14%)  2/702 (0.28%) 
Dyspnoea exertional  1  0/701 (0.00%)  1/702 (0.14%) 
Emphysema  1  0/701 (0.00%)  2/702 (0.28%) 
Haemoptysis  1  0/701 (0.00%)  1/702 (0.14%) 
Haemothorax  1  0/701 (0.00%)  1/702 (0.14%) 
Hypoxia  1  1/701 (0.14%)  1/702 (0.14%) 
Interstitial lung disease  1  6/701 (0.86%)  3/702 (0.43%) 
Lung infiltration  1  0/701 (0.00%)  1/702 (0.14%) 
Organising pneumonia  1  1/701 (0.14%)  0/702 (0.00%) 
Pleural effusion  1  2/701 (0.29%)  4/702 (0.57%) 
Pneumonia aspiration  1  0/701 (0.00%)  1/702 (0.14%) 
Pneumonitis  1  1/701 (0.14%)  5/702 (0.71%) 
Pneumothorax  1  1/701 (0.14%)  1/702 (0.14%) 
Pulmonary embolism  1  4/701 (0.57%)  4/702 (0.57%) 
Pulmonary fibrosis  1  0/701 (0.00%)  1/702 (0.14%) 
Pulmonary oedema  1  0/701 (0.00%)  1/702 (0.14%) 
Respiratory failure  1  2/701 (0.29%)  0/702 (0.00%) 
Cough  1  0/701 (0.00%)  1/702 (0.14%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  1/701 (0.14%)  0/702 (0.00%) 
Skin ulcer  1  1/701 (0.14%)  2/702 (0.28%) 
Vascular disorders     
Deep vein thrombosis  1  0/701 (0.00%)  2/702 (0.28%) 
Haemorrhage  1  0/701 (0.00%)  1/702 (0.14%) 
Hypertension  1  0/701 (0.00%)  1/702 (0.14%) 
Hypotension  1  2/701 (0.29%)  3/702 (0.43%) 
Orthostatic hypotension  1  1/701 (0.14%)  0/702 (0.00%) 
Phlebitis  1  0/701 (0.00%)  1/702 (0.14%) 
Thrombophlebitis  1  2/701 (0.29%)  0/702 (0.00%) 
Thrombophlebitis superficial  1  0/701 (0.00%)  1/702 (0.14%) 
Venous occlusion  1  0/701 (0.00%)  1/702 (0.14%) 
Venous thrombosis limb  1  0/701 (0.00%)  1/702 (0.14%) 
Axillary vein thrombosis  1  1/701 (0.14%)  0/702 (0.00%) 
Jugular vein thrombosis  1  1/701 (0.14%)  0/702 (0.00%) 
Subclavian vein thrombosis  1  1/701 (0.14%)  0/702 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 21.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   613/701 (87.45%)   646/702 (92.02%) 
Blood and lymphatic system disorders     
Anaemia  1  101/701 (14.41%)  96/702 (13.68%) 
Febrile neutropenia  1  44/701 (6.28%)  52/702 (7.41%) 
Leukopenia  1  90/701 (12.84%)  117/702 (16.67%) 
Neutropenia  1  269/701 (38.37%)  315/702 (44.87%) 
Thrombocytopenia  1  16/701 (2.28%)  58/702 (8.26%) 
Gastrointestinal disorders     
Abdominal pain  1  47/701 (6.70%)  47/702 (6.70%) 
Abdominal pain upper  1  41/701 (5.85%)  38/702 (5.41%) 
Constipation  1  177/701 (25.25%)  167/702 (23.79%) 
Diarrhoea  1  91/701 (12.98%)  113/702 (16.10%) 
Dyspepsia  1  43/701 (6.13%)  44/702 (6.27%) 
Nausea  1  199/701 (28.39%)  210/702 (29.91%) 
Stomatitis  1  65/701 (9.27%)  47/702 (6.70%) 
Vomiting  1  75/701 (10.70%)  105/702 (14.96%) 
General disorders     
Asthenia  1  74/701 (10.56%)  76/702 (10.83%) 
Chills  1  37/701 (5.28%)  132/702 (18.80%) 
Fatigue  1  124/701 (17.69%)  136/702 (19.37%) 
Mucosal inflammation  1  36/701 (5.14%)  45/702 (6.41%) 
Oedema peripheral  1  40/701 (5.71%)  35/702 (4.99%) 
Pyrexia  1  75/701 (10.70%)  137/702 (19.52%) 
Infections and infestations     
Upper respiratory tract infection  1  49/701 (6.99%)  43/702 (6.13%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  162/701 (23.11%)  251/702 (35.75%) 
Investigations     
Alanine Aminotransferase Increased  1  29/701 (4.14%)  39/702 (5.56%) 
Metabolism and nutrition disorders     
Decreased appetite  1  74/701 (10.56%)  98/702 (13.96%) 
Hypokalaemia  1  55/701 (7.85%)  67/702 (9.54%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  41/701 (5.85%)  58/702 (8.26%) 
Arthralgia  1  28/701 (3.99%)  37/702 (5.27%) 
Nervous system disorders     
Dizziness  1  29/701 (4.14%)  48/702 (6.84%) 
Dysgeusia  1  38/701 (5.42%)  44/702 (6.27%) 
Headache  1  58/701 (8.27%)  75/702 (10.68%) 
Neuropathy peripheral  1  88/701 (12.55%)  87/702 (12.39%) 
Paraesthesia  1  50/701 (7.13%)  55/702 (7.83%) 
Peripheral sensory neuropathy  1  57/701 (8.13%)  54/702 (7.69%) 
Psychiatric disorders     
Insomnia  1  61/701 (8.70%)  79/702 (11.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  66/701 (9.42%)  88/702 (12.54%) 
Dyspnoea  1  31/701 (4.42%)  52/702 (7.41%) 
Oropharyngeal pain  1  38/701 (5.42%)  43/702 (6.13%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  144/701 (20.54%)  148/702 (21.08%) 
Rash  1  45/701 (6.42%)  17/702 (2.42%) 
Vascular disorders     
Hypertension  1  27/701 (3.85%)  40/702 (5.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 21.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01287741    
Other Study ID Numbers: BO21005
2010-024194-39
First Submitted: January 31, 2011
First Posted: February 1, 2011
Results First Submitted: April 7, 2017
Results First Posted: August 17, 2017
Last Update Posted: April 12, 2019