A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

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ClinicalTrials.gov Identifier: NCT01332968

Recruitment Status : Completed

First Posted : April 11, 2011

Results First Posted : June 7, 2017

Last Update Posted : August 11, 2022

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Sponsor:

Collaborators:

German Low Grade Lymphoma Study Group

Institute of Cancer Research, United Kingdom

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	Non-Hodgkin's Lymphoma
Interventions	Drug: Obinutuzumab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Bendamustine Drug: Rituximab
Enrollment	1401

Participant Flow

Recruitment Details	The study was conducted at 177 centers in 18 countries.
Pre-assignment Details	Eleven participants withdrew from the study after randomization but prior to receiving study treatment.


Arm/Group Title	Rituximab+Chemotherapy - Induction Period	Obinutuzumab+Chemotherapy - Induction Period	Rituximab+Chemotherapy - Maintenance Period	Obinutuzumab+Chemotherapy - Maintenance Period	Rituximab+Chemotherapy - Observation Period	Obinutuzumab+Chemotherapy - Observation Period	Rituximab+Chemotherapy - Follow-Up Period	Obinutuzumab+Chemotherapy - Follow-Up Period
Arm/Group Description	Participants received either 8 cycl...	Participants received either 8 cycl...	The induction period was followed b...	The induction period was followed b...	Rituximab+Chemotherapy - Observatio...	Obinutuzumab+Chemotherapy - Observa...	Finally, participants were followed...	Finally, participants were followed...
Arm/Group Description	Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.	The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.	Rituximab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.	Obinutuzumab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.	Finally, participants were followed during a 5-year follow-up period.	Finally, participants were followed during a 5-year follow-up period.
Period Title: Induction Period
Started	699	702	0	0	0	0	0	0
Completed	641	646	0	0	0	0	0	0
Not Completed	58	56	0	0	0	0	0	0
Reason Not Completed
Adverse Event	23	26	0	0	0	0	0	0
Death	1	4	0	0	0	0	0	0
Non-compliance	1	0	0	0	0	0	0	0
Other	2	2	0	0	0	0	0	0
Physician Decision	6	1	0	0	0	0	0	0
Progressive Disease	15	7	0	0	0	0	0	0
Protocol Violation	3	4	0	0	0	0	0	0
Withdrawal by Subject	3	5	0	0	0	0	0	0
Randomised but not treated	4	7	0	0	0	0	0	0
Period Title: Maintenance/Observation Period
Started	0	0	612	624	12	11	0	0
Completed	0	0	451	475	12	10	0	0
Not Completed	0	0	161	149	0	1	0	0
Reason Not Completed
Adverse Event	0	0	53	66	0	0	0	0
Death	0	0	5	6	0	0	0	0
Lost to Follow-up	0	0	1	2	0	0	0	0
Non-compliance	0	0	4	3	0	0	0	0
Other	0	0	4	7	0	0	0	0
Physician Decision	0	0	14	19	0	1	0	0
Progressive Disease	0	0	72	40	0	0	0	0
Protocol Violation	0	0	1	1	0	0	0	0
Withdrawal by Subject	0	0	7	5	0	0	0	0
Period Title: Follow-Up Period
Started	0	0	0	0	0	0	554	602
Completed	0	0	0	0	0	0	324	367
Not Completed	0	0	0	0	0	0	230	235
Reason Not Completed
Adverse Event	0	0	0	0	0	0	0	4
Death	0	0	0	0	0	0	27	30
Lost to Follow-up	0	0	0	0	0	0	11	15
Non-compliance	0	0	0	0	0	0	4	9
Other	0	0	0	0	0	0	18	21
Physician Decision	0	0	0	0	0	0	12	15
Progressive Disease	0	0	0	0	0	0	126	106
Protocol Violation	0	0	0	0	0	0	1	0
Withdrawal by Subject	0	0	0	0	0	0	29	32
No reason provided	0	0	0	0	0	0	2	3

Baseline Characteristics

Arm/Group Title		Rituximab+Chemotherapy - Induction Period	Obinutuzumab+Chemotherapy - Induction Period	Total
Arm/Group Description		Participants received either 8 cycl...	Participants received either 8 cycl...	Total of all reporting groups
Arm/Group Description		Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Total of all reporting groups
Overall Number of Baseline Participants		699	702	1401
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	699 participants	702 participants	1401 participants
		58.1 (12.3)	58.9 (11.6)	58.5 (11.9)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	699 participants	702 participants	1401 participants
	Female	374 53.5%	365 52.0%	739 52.7%
	Male	325 46.5%	337 48.0%	662 47.3%
Age Continuous in Follicular Lymphoma Sub-Population ^[1] Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	699 participants	702 participants	1401 participants
		57.7 (12.2)	58.2 (11.5)	57.9 (11.9)
		[1] Measure Description: Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm).
Gender in Follicular Lymphoma Sub-Population ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	601 participants	601 participants	1202 participants
	Female	321 53.4%	318 52.9%	639 53.2%
	Male	280 46.6%	283 47.1%	563 46.8%
		[1] Measure Description: Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm). [2] Measure Analysis Population Description: As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Description	Progression-free survival in participants with follicular lymphoma was...
Description	Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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 data cut-off (up to approximately 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	24.0	16.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95% 0.51 to 0.85
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Description	Progression-free survival in participants with follicular lymphoma was...
Description	Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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 final analysis (up to 10 years)

Outcome Measure Data

Analysis Population Description

The FL ITT population was defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	40.6	34.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0055
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% 0.64 to 0.93
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Description	Progression-free survival in the overall study population was defined ...
Description	Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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 CT/MRI.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	699	702
Measure Type: Number Unit of Measure: percentage of participants with event
	41.5	34.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0028
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% 0.65 to 0.91
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Description	Progression-free survival in the participants with follicular lymphoma...
Description	Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. 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 CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	23.5	18.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0118
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95% 0.56 to 0.93
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Description	Progression-free survival in the overall study population was defined ...
Description	Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. 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 CT/MRI.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	699	702
Measure Type: Number Unit of Measure: percentage of participants with event
	24.6	18.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0038
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	95% 0.57 to 0.90
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Description	Overall response in the follicular lymphoma population was defined as ...
Description	Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		601	601
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	519 participants	530 participants
Without PET		86.4	88.2
With PET	Number Analyzed	242 participants	254 participants
With PET		81.2	85.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95% -2.02 to 5.68
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.17
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	4.3
	Confidence Interval	(2-Sided) 95% -1.8 to 10.5
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Overall Response (Overall Study Population), Investigator-Assessed
Description	Overall response in the overall study population was defined as percen...
Description	Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		699	702
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	599 participants	613 participants
Without PET		85.7	87.3
With PET	Number Analyzed	270 participants	274 participants
With PET		81.8	85.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.33
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95% -2.0 to 5.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.17
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95% -2.3 to 9.4
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Description	Percentage of participants with complete response in the follicular ly...
Description	Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		601	601
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	145 participants	112 participants
Without PET		24.1	18.6
With PET	Number Analyzed	169 participants	184 participants
With PET		56.7	62.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 95% -10.2 to -0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.32
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95% -2.8 to 13.3
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Complete Response (Overall Study Population), Investigator-Assessed
Description	Percentage of participants with complete response in the overall study...
Description	Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		699	702
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	163 participants	129 participants
Without PET		23.3	18.4
With PET	Number Analyzed	188 participants	196 participants
With PET		57.0	61.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	-4.9
	Confidence Interval	95% -9.3 to 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.33
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	4.1
	Confidence Interval	95% -3.6 to 11.8
	Estimation Comments	[Not Specified]

10.Secondary Outcome


Title	Overall Response (Follicular Lymphoma Population), IRC-Assessed
Description	Overall response in the follicular lymphoma population was defined as ...
Description	Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		601	601
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	529 participants	549 participants
Without PET		88.0	91.3
With PET	Number Analyzed	254 participants	263 participants
With PET		85.2	88.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.052
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95% -0.19 to 6.85
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95% -2.3 to 8.9
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Overall Response (Overall Study Population), IRC-Assessed
Description	Overall response in the overall study population was defined as percen...
Description	Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		699	702
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	606 participants	631 participants
Without PET		86.7	89.9
With PET	Number Analyzed	330 participants	321 participants
With PET		83.3	87.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.049
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95% -0.3 to 6.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.22
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95% -1.7 to 9.5
	Estimation Comments	[Not Specified]

12.Secondary Outcome


Title	Complete Response (Follicular Lymphoma Population), IRC-Assessed
Description	Percentage of participants with complete response in the follicular ly...
Description	Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		601	601
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	161 participants	171 participants
Without PET		26.8	28.5
With PET	Number Analyzed	178 participants	212 participants
With PET		59.7	71.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.58
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95% -3.5 to 6.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95% 3.9 to 19.4
	Estimation Comments	[Not Specified]

13.Secondary Outcome


Title	Complete Response (Overall Study Population), IRC-Assessed
Description	Percentage of participants with complete response in the overall study...
Description	Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Time Frame	Baseline up to end of induction period (up to approximately 7 months)]

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		699	702
Measure Type: Number Unit of Measure: percentage of participants with event
Without PET	Number Analyzed	184 participants	190 participants
Without PET		26.3	27.1
With PET	Number Analyzed	196 participants	223 participants
With PET		59.4	69.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	Without PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.80
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95% -4.0 to 5.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	With PET
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in %
	Estimated Value	10.1
	Confidence Interval	95% 2.6 to 17.6
	Estimation Comments	[Not Specified]

14.Secondary Outcome


Title	Overall Survival (Follicular Lymphoma Population)
Description	Overall survival in the follicular lymphoma population was defined as ...
Description	Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.
Time Frame	Baseline up to 10 years

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	14.3	12.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3577
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.86
	Confidence Interval	95% 0.63 to 1.18
	Estimation Comments	[Not Specified]

15.Secondary Outcome


Title	Overall Survival (Overall Study Population)
Description	Overall survival in the overall study population was defined as the ti...
Description	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. Reported is the percentage of participants with event.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	699	702
Measure Type: Number Unit of Measure: percentage of participants with event
	10.2	8.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.25
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	95% 0.58 to 1.16
	Estimation Comments	[Not Specified]

16.Secondary Outcome


Title	Event-Free Survival (Follicular Lymphoma Population)
Description	Event-free survival in the follicular lymphoma population was defined ...
Description	Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment 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. Reported is the percentage of participants with an event.
Time Frame	Baseline up to 10 years

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	42.9	35.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0015
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95% 0.62 to 0.89
	Estimation Comments	[Not Specified]

17.Secondary Outcome


Title	Event-Free Survival (Overall Study Population)
Description	Event-free survival in the overall study population was defined as the...
Description	Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment 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. Reported is the percentage of participants with event.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	699	702
Measure Type: Number Unit of Measure: percentage of participants with event
	30.6	22.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.69
	Confidence Interval	95% 0.56 to 0.85
	Estimation Comments	[Not Specified]

18.Secondary Outcome


Title	Disease-Free Survival (Follicular Lymphoma Population)
Description	Disease-free survival in the follicular lymphoma population was define...
Description	Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). 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. Reported is the percentage of participants with event.
Time Frame	From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	330	355
Measure Type: Number Unit of Measure: percentage of participants with event
	27.9	26.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95% 0.71 to 1.27
	Estimation Comments	[Not Specified]

19.Secondary Outcome


Title	Disease-Free Survival (Overall Study Population)
Description	Disease-free survival in the overall study population was defined as t...
Description	Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the 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. Reported is the percentage of participants with event.
Time Frame	From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	320	343
Measure Type: Number Unit of Measure: percentage of participants with event
	14.9	11.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95% 0.50 to 1.19
	Estimation Comments	[Not Specified]

20.Secondary Outcome


Title	Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
Description	DOR was defined as the time from first occurrence of a documented CR o...
Description	DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=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 nodules must have regressed by >/= 50%. 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	From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	568	571
Measure Type: Number Unit of Measure: percentage of participants with event
	39.3	33.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.63 to 0.93
	Estimation Comments	[Not Specified]

21.Secondary Outcome


Title	Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
Description	DOR was defined as the time from first occurrence of a documented CR o...
Description	DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=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 nodules must have regressed by >/= 50%. 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	From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)

Outcome Measure Data

Analysis Population Description

Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	656	659
Measure Type: Number Unit of Measure: percentage of participants with event
	25.5	18.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.69
	Confidence Interval	95% 0.55 to 0.88
	Estimation Comments	[Not Specified]

22.Secondary Outcome


Title	Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Description	Time to next anti-lymphoma treatment was defined as the time from the ...
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. Reported is the percentage of participants with event.
Time Frame	Baseline up to 10 years

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	601	601
Measure Type: Number Unit of Measure: percentage of participants with event
	34.8	26.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.58 to 0.87
	Estimation Comments	[Not Specified]

23.Secondary Outcome


Title	Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Description	Time to next anti-lymphoma treatment was defined as the time from the ...
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. Reported is the percentage of participants with event.
Time Frame	Baseline up to data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	699	702
Measure Type: Number Unit of Measure: percentage of participants with event
	21.6	15.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.70
	Confidence Interval	95% 0.54 to 0.89
	Estimation Comments	[Not Specified]

24.Secondary Outcome


Title	Percentage of Participants With Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant a...
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 10 years

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.


Arm/Group Title	Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:	Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed	692	698
Measure Type: Number Unit of Measure: percentage of participants
	99.6	99.9

25.Secondary Outcome


Title	Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
Description	FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physic...
Description	FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.
Time Frame	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants received either 8 cycl...	Participants received either 8 cycl...
Arm/Group Description:		Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		557	566
Mean (Standard Deviation) Unit of Measure: units on a scale
Physical Well-being (PW), Baseline	Number Analyzed	557 participants	566 participants
Physical Well-being (PW), Baseline		23.36 (4.77)	23.14 (4.85)
PW Change, Cycle 3, Day 1	Number Analyzed	511 participants	496 participants
PW Change, Cycle 3, Day 1		-0.91 (4.54)	-0.21 (4.59)
PW Change, End Induction	Number Analyzed	482 participants	480 participants
PW Change, End Induction		-0.06 (4.83)	0.56 (5.14)
PW Change, Maint Month 2	Number Analyzed	362 participants	398 participants
PW Change, Maint Month 2		0.83 (4.76)	1.42 (5.09)
PW Change, Maint Month 12	Number Analyzed	362 participants	406 participants
PW Change, Maint Month 12		1.14 (4.29)	1.34 (4.74)
PW Change, End Maint	Number Analyzed	411 participants	437 participants
PW Change, End Maint		0.88 (4.54)	1.33 (5.00)
Social/Family Well-being , Baseline	Number Analyzed	555 participants	563 participants
Social/Family Well-being , Baseline		22.84 (4.92)	23.28 (4.77)
S/FW Change, Cycle 3 Day 1	Number Analyzed	506 participants	492 participants
S/FW Change, Cycle 3 Day 1		-0.52 (4.03)	-0.67 (3.92)
S/FW Change, End Induction	Number Analyzed	482 participants	475 participants
S/FW Change, End Induction		-0.46 (4.77)	-0.56 (5.00)
S/FW Change, Maint Month 2	Number Analyzed	359 participants	396 participants
S/FW Change, Maint Month 2		-0.39 (4.72)	-0.67 (4.68)
S/FW Change, Maint Month 12	Number Analyzed	359 participants	403 participants
S/FW Change, Maint Month 12		-0.61 (5.56)	-0.97 (5.34)
S/FW Change, End Maint	Number Analyzed	410 participants	436 participants
S/FW Change, End Maint		-0.93 (5.67)	-0.71 (5.54)
Emotional Well-being (EW), Baseline	Number Analyzed	556 participants	563 participants
Emotional Well-being (EW), Baseline		17.64 (4.19)	17.87 (4.13)
EW Change, Cycle 3 Day 1	Number Analyzed	503 participants	490 participants
EW Change, Cycle 3 Day 1		1.49 (3.40)	1.35 (3.35)
EW Change, End Induction	Number Analyzed	478 participants	476 participants
EW Change, End Induction		1.16 (3.90)	1.14 (3.87)
EW Change, Maint Month 2	Number Analyzed	359 participants	396 participants
EW Change, Maint Month 2		1.77 (3.88)	1.49 (4.16)
EW Change, Maint Month 12	Number Analyzed	360 participants	402 participants
EW Change, Maint Month 12		1.45 (3.92)	1.46 (3.88)
EW Change, End Maint	Number Analyzed	405 participants	435 participants
EW Change, End Maint		1.43 (3.98)	1.49 (3.99)
Functional Well-being (FW), Baseline	Number Analyzed	556 participants	563 participants
Functional Well-being (FW), Baseline		18.66 (6.19)	18.76 (5.98)
FW Change, Cycle 3 Day 1	Number Analyzed	504 participants	488 participants
FW Change, Cycle 3 Day 1		-0.30 (5.30)	-0.07 (5.24)
FW Change, End Induction	Number Analyzed	480 participants	476 participants
FW Change, End Induction		0.44 (5.63)	0.93 (5.85)
FW Change, Maint Month 2	Number Analyzed	359 participants	396 participants
FW Change, Maint Month 2		1.04 (5.31)	1.25 (6.02)
FW Change, Maint Month 12	Number Analyzed	360 participants	402 participants
FW Change, Maint Month 12		1.84 (5.54)	1.65 (5.95)
FW Change, End Maint	Number Analyzed	406 participants	436 participants
FW Change, End Maint		1.40 (6.12)	1.72 (6.16)

26.Secondary Outcome


Title	Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
Description	The FACT-Lym TOI Score for the follicular lymphoma population was deri...
Description	The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Time Frame	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants received either 8 cycl...	Participants received either 8 cycl...
Arm/Group Description:		Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		559	567
Mean (Standard Deviation) Unit of Measure: units on a scale
TOI Score, Baseline	Number Analyzed	559 participants	567 participants
TOI Score, Baseline		86.61 (18.16)	86.94 (18.05)
TOI Score Change, Cycle 3 Day 1	Number Analyzed	514 participants	497 participants
TOI Score Change, Cycle 3 Day 1		0.46 (15.03)	2.18 (15.95)
TOI Score Change, End Induction	Number Analyzed	485 participants	481 participants
TOI Score Change, End Induction		2.91 (17.00)	4.57 (16.71)
TOI Score Change, Maint M2	Number Analyzed	363 participants	400 participants
TOI Score Change, Maint M2		6.22 (16.16)	7.17 (16.57)
TOI Score Change, Maint M12	Number Analyzed	362 participants	408 participants
TOI Score Change, Maint M12		7.61 (15.62)	7.20 (16.75)
TOI Score Change, End Maint	Number Analyzed	412 participants	440 participants
TOI Score Change, End Maint		6.23 (17.06)	7.44 (16.96)

27.Secondary Outcome


Title	Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
Description	The FACT-Lym Individual Subscale Lymphoma Score for the follicular lym...
Description	The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Time Frame	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants received either 8 cycl...	Participants received either 8 cycl...
Arm/Group Description:		Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		556	563
Mean (Standard Deviation) Unit of Measure: units on a scale
Lymphoma, Baseline	Number Analyzed	556 participants	563 participants
Lymphoma, Baseline		45.01 (9.37)	45.54 (9.29)
Lymphoma Change, Cycle 3 Day 1	Number Analyzed	509 participants	491 participants
Lymphoma Change, Cycle 3 Day 1		2.04 (7.18)	2.71 (7.46)
Lymphoma Change, End Induction	Number Analyzed	477 participants	478 participants
Lymphoma Change, End Induction		2.99 (8.63)	3.01 (8.36)
Lymphoma Change, Maint Month 2	Number Analyzed	360 participants	395 participants
Lymphoma Change, Maint Month 2		4.80 (8.29)	4.52 (8.32)
Lymphoma Change, Maint Month 12	Number Analyzed	360 participants	404 participants
Lymphoma Change, Maint Month 12		4.93 (8.34)	4.27 (8.31)
Lymphoma Change, End Maint	Number Analyzed	407 participants	438 participants
Lymphoma Change, End Maint		4.31 (8.81)	4.57 (8.54)

28.Secondary Outcome


Title	Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
Description	The FACT-Lym Total Score for the follicular lymphoma population was de...
Description	The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Time Frame	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

Outcome Measure Data

Analysis Population Description

The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants received either 8 cycl...	Participants received either 8 cycl...
Arm/Group Description:		Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.	Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		552	559
Mean (Standard Deviation) Unit of Measure: units on a scale
Total Score, Baseline	Number Analyzed	552 participants	559 participants
Total Score, Baseline		127.40 (22.43)	128.42 (22.16)
Total Score Change, Cycle 3 Day 1	Number Analyzed	499 participants	484 participants
Total Score Change, Cycle 3 Day 1		1.98 (17.01)	3.21 (17.12)
Total Score Change, End Induction	Number Analyzed	471 participants	471 participants
Total Score Change, End Induction		4.18 (19.75)	5.10 (20.03)
Total Score Change, Maint Month 2	Number Analyzed	356 participants	392 participants
Total Score Change, Maint Month 2		8.40 (19.16)	8.13 (19.80)
Total Score Change, Maint Month 12	Number Analyzed	358 participants	396 participants
Total Score Change, Maint Month 12		8.87 (19.31)	7.90 (19.55)
Total Score Change, End Maint	Number Analyzed	401 participants	433 participants
Total Score Change, End Maint		7.43 (19.88)	8.80 (20.57)

29.Secondary Outcome


Title	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
Description	The EQ-5D is a quality of life questionnaire with five questions, each...
Description	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.
Time Frame	Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		558	559
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline Induction	Number Analyzed	558 participants	559 participants
Baseline Induction		0.80 (0.24)	0.81 (0.21)
Change Baseline, Cycle 1 Day 1	Number Analyzed	0 participants	0 participants
Change Baseline, Cycle 3 Day 1	Number Analyzed	505 participants	487 participants
Change Baseline, Cycle 3 Day 1		0.03 (0.21)	0.03 (0.20)
Change Baseline, Induction Compl	Number Analyzed	468 participants	466 participants
Change Baseline, Induction Compl		0.04 (0.23)	0.03 (0.22)
Change Baseline, Maint/Obs Month 2	Number Analyzed	348 participants	377 participants
Change Baseline, Maint/Obs Month 2		0.05 (0.23)	0.06 (0.22)
Change from Baseline, Maint/Obs Month 12	Number Analyzed	2 participants	1 participants
Change from Baseline, Maint/Obs Month 12		0.00 (0.00)	-0.20 ^[1] (NA)
Change Baseline, Maint/Obs Completion	Number Analyzed	0 participants	1 participants
Change Baseline, Maint/Obs Completion			-0.10 ^[1] (NA)

[1]

NA = NE = Not estimable based on 1 participant evaluated

30.Secondary Outcome


Title	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
Description	The EQ-5D is a quality of life questionnaire with five questions, each...
Description	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.
Time Frame	Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		536	547
Mean (Standard Deviation) Unit of Measure: units on a scale
Change Baseline, Maint/Obs Month 2	Number Analyzed	11 participants	14 participants
Change Baseline, Maint/Obs Month 2		0.04 (0.34)	0.04 (0.14)
Change Baseline, Maint/Obs Month 12	Number Analyzed	536 participants	547 participants
Change Baseline, Maint/Obs Month 12		0.06 (0.24)	0.06 (0.21)
Change Baseline, Maint/Obs Completion	Number Analyzed	402 participants	421 participants
Change Baseline, Maint/Obs Completion		0.03 (0.23)	0.05 (0.23)

31.Secondary Outcome


Title	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
Description	The EQ-5D is a quality of life questionnaire with five questions, each...
Description	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.
Time Frame	Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Rituximab+Chemotherapy	Obinutuzumab+Chemotherapy
Arm/Group Description:		Participants will receive either 8 ...	Participants will receive either 8 ...
Arm/Group Description:		Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.	Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Overall Number of Participants Analyzed		563	564
Mean (Standard Deviation) Unit of Measure: units on a scale
Change Baseline, Follow-Up Month 36	Number Analyzed	238 participants	248 participants
Change Baseline, Follow-Up Month 36		0.05 (0.24)	0.06 (0.23)
Change Baseline, Follow-Up Month 48	Number Analyzed	73 participants	80 participants
Change Baseline, Follow-Up Month 48		0.05 (0.20)	0.06 (0.23)

Adverse Events

Time Frame	Baseline up to 10 years
Adverse Event Reporting Description	The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.

Arm/Group Title	Rituximab+Chemotherapy		Obinutuzumab+Chemotherapy
Arm/Group Description	Participants will receive either 8 ...		Participants will receive either 8 ...
Arm/Group Description	Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.		Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
All-Cause Mortality
	Rituximab+Chemotherapy		Obinutuzumab+Chemotherapy
	Affected / at Risk (%)		Affected / at Risk (%)
Total	111/692 (16.04%)		104/698 (14.90%)
Serious Adverse Events Serious Adverse Events
	Rituximab+Chemotherapy		Obinutuzumab+Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	309/692 (44.65%)		361/698 (51.72%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	1/692 (0.14%)	1	6/698 (0.86%)	7
AUTOIMMUNE HAEMOLYTIC ANAEMIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
DISSEMINATED INTRAVASCULAR COAGULATION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
FEBRILE NEUTROPENIA ^† 1	23/692 (3.32%)	31	36/698 (5.16%)	48
GRANULOCYTOPENIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HAEMOLYSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HAEMOLYTIC ANAEMIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
IMMUNE THROMBOCYTOPENIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
LEUKOPENIA ^† 1	6/692 (0.87%)	10	4/698 (0.57%)	4
MYELOSUPPRESSION ^† 1	0/692 (0.00%)	0	3/698 (0.43%)	4
NEUTROPENIA ^† 1	33/692 (4.77%)	46	28/698 (4.01%)	31
SPLENOMEGALY ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
THROMBOCYTOPENIA ^† 1	3/692 (0.43%)	3	5/698 (0.72%)	12
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION ^† 1	0/692 (0.00%)	0	4/698 (0.57%)	5
ANGINA PECTORIS ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
AORTIC VALVE STENOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ARRHYTHMIA ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
ATRIAL FIBRILLATION ^† 1	2/692 (0.29%)	2	9/698 (1.29%)	11
ATRIAL FLUTTER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BRADYCARDIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CARDIAC ARREST ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
CARDIAC FAILURE ^† 1	3/692 (0.43%)	3	2/698 (0.29%)	3
CARDIAC FAILURE CONGESTIVE ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
CARDIO-RESPIRATORY ARREST ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CARDIOGENIC SHOCK ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
CORONARY ARTERY DISEASE ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
CORONARY ARTERY STENOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
MYOCARDIAL INFARCTION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
MYOCARDIAL ISCHAEMIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PALPITATIONS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RIGHT VENTRICULAR FAILURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SINUS BRADYCARDIA ^† 1	0/692 (0.00%)	0	5/698 (0.72%)	5
SINUS TACHYCARDIA ^† 1	0/692 (0.00%)	0	3/698 (0.43%)	3
SUPRAVENTRICULAR TACHYCARDIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
TACHYCARDIA ^† 1	0/692 (0.00%)	0	3/698 (0.43%)	3
VENTRICULAR TACHYCARDIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Congenital, familial and genetic disorders
HEREDITARY MOTOR AND SENSORY NEUROPATHY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Ear and labyrinth disorders
DEAFNESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
EAR PAIN ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
VERTIGO ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Eye disorders
CORNEAL OPACITY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	6/692 (0.87%)	6	10/698 (1.43%)	11
ABDOMINAL PAIN UPPER ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
ASCITES ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	2
COLITIS ^† 1	2/692 (0.29%)	2	3/698 (0.43%)	3
CONSTIPATION ^† 1	1/692 (0.14%)	1	3/698 (0.43%)	3
CROHN'S DISEASE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DIARRHOEA ^† 1	7/692 (1.01%)	8	11/698 (1.58%)	12
DYSPEPSIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ENTEROVESICAL FISTULA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
FAECALOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTRIC HAEMORRHAGE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTRIC ULCER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTRITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTRITIS EROSIVE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
GASTROENTERITIS EOSINOPHILIC ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
GASTROOESOPHAGEAL REFLUX DISEASE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HAEMATEMESIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HAEMORRHOIDS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HIATUS HERNIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ILEUS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INGUINAL HERNIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
INTESTINAL ISCHAEMIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
INTESTINAL OBSTRUCTION ^† 1	0/692 (0.00%)	0	4/698 (0.57%)	5
INTESTINAL POLYP ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INTESTINAL VILLI ATROPHY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
LARGE INTESTINAL OBSTRUCTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
LARGE INTESTINE POLYP ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MELAENA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MIKULICZ'S SYNDROME ^† 1	1/692 (0.14%)	2	0/698 (0.00%)	0
MOUTH ULCERATION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
NAUSEA ^† 1	3/692 (0.43%)	3	5/698 (0.72%)	5
OBSTRUCTIVE PANCREATITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PANCREATITIS ^† 1	1/692 (0.14%)	1	4/698 (0.57%)	5
PANCREATITIS ACUTE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
RECTAL HAEMORRHAGE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SMALL INTESTINAL OBSTRUCTION ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
SUBACUTE PANCREATITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SWOLLEN TONGUE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
UMBILICAL HERNIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
UPPER GASTROINTESTINAL HAEMORRHAGE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
VOMITING ^† 1	9/692 (1.30%)	13	5/698 (0.72%)	5
General disorders
ADVERSE DRUG REACTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CHEST DISCOMFORT ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
CHEST PAIN ^† 1	4/692 (0.58%)	4	1/698 (0.14%)	1
CHILLS ^† 1	3/692 (0.43%)	3	4/698 (0.57%)	4
CYST RUPTURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DEATH ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1	2/692 (0.29%)	2	3/698 (0.43%)	3
HYPERPLASIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HYPERTHERMIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ILL-DEFINED DISORDER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INFLUENZA LIKE ILLNESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INFUSION SITE EXTRAVASATION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MUCOSAL INFLAMMATION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
MULTIPLE ORGAN DYSFUNCTION SYNDROME ^† 1	3/692 (0.43%)	3	0/698 (0.00%)	0
NON-CARDIAC CHEST PAIN ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
OEDEMA PERIPHERAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PAIN ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
PYREXIA ^† 1	23/692 (3.32%)	24	37/698 (5.30%)	43
STENT-GRAFT ENDOLEAK ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SWELLING FACE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Hepatobiliary disorders
BILE DUCT STENOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BILE DUCT STONE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	2
BILIARY COLIC ^† 1	1/692 (0.14%)	1	3/698 (0.43%)	3
CHOLANGITIS ^† 1	1/692 (0.14%)	2	0/698 (0.00%)	0
CHOLECYSTITIS ^† 1	6/692 (0.87%)	7	5/698 (0.72%)	6
CHOLECYSTITIS ACUTE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CHOLELITHIASIS ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
DRUG-INDUCED LIVER INJURY ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
HEPATIC CIRRHOSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HEPATIC FUNCTION ABNORMAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HEPATITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HEPATITIS ACUTE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Immune system disorders
ALLERGY TO ARTHROPOD BITE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ANAPHYLACTIC REACTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ANAPHYLACTIC SHOCK ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CYTOKINE RELEASE SYNDROME ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
DRUG HYPERSENSITIVITY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HYPERSENSITIVITY ^† 1	3/692 (0.43%)	3	0/698 (0.00%)	0
HYPOGAMMAGLOBULINAEMIA ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
Infections and infestations
ABDOMINAL SEPSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ABSCESS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ABSCESS INTESTINAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
APPENDICITIS ^† 1	3/692 (0.43%)	3	1/698 (0.14%)	1
ARTHRITIS BACTERIAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ARTHRITIS INFECTIVE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ATYPICAL PNEUMONIA ^† 1	3/692 (0.43%)	3	1/698 (0.14%)	1
BACTERAEMIA ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
BACTERIAL TRACHEITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BK VIRUS INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BREAST ABSCESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BRONCHITIS ^† 1	3/692 (0.43%)	3	9/698 (1.29%)	9
CAMPYLOBACTER INFECTION ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
CATHETER SITE CELLULITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CELLULITIS ^† 1	3/692 (0.43%)	3	4/698 (0.57%)	4
CHRONIC SINUSITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CLOSTRIDIUM DIFFICILE COLITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
COMPLICATED APPENDICITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CYSTITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CYTOMEGALOVIRUS INFECTION ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
DEVICE RELATED INFECTION ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
DEVICE RELATED SEPSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DIVERTICULITIS ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	2
ENCEPHALITIS ENTEROVIRAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ENDOCARDITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ENTEROCOCCAL INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
EPIGLOTTITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ESCHERICHIA INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ESCHERICHIA URINARY TRACT INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
FEBRILE INFECTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
GASTROENTERITIS ^† 1	1/692 (0.14%)	1	7/698 (1.00%)	7
GASTROENTERITIS ESCHERICHIA COLI ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTROENTERITIS VIRAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HERPES ZOSTER ^† 1	9/692 (1.30%)	9	9/698 (1.29%)	9
HERPES ZOSTER INFECTION NEUROLOGICAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HERPES ZOSTER OTICUS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INFECTED CYST ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INFECTION ^† 1	10/692 (1.45%)	11	6/698 (0.86%)	7
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE ^† 1	2/692 (0.29%)	2	3/698 (0.43%)	3
INFLUENZA ^† 1	0/692 (0.00%)	0	4/698 (0.57%)	4
INTERVERTEBRAL DISCITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
LOWER RESPIRATORY TRACT INFECTION ^† 1	9/692 (1.30%)	9	13/698 (1.86%)	23
MASTOIDITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
MENINGITIS ENTEROVIRAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MUCOSAL INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
NEUROBORRELIOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
NEUTROPENIC INFECTION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
NEUTROPENIC SEPSIS ^† 1	5/692 (0.72%)	8	6/698 (0.86%)	9
OESOPHAGEAL CANDIDIASIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
OESOPHAGEAL INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
OOPHORITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ORAL HERPES ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
OTITIS MEDIA CHRONIC ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
OVARIAN BACTERIAL INFECTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PARAPHARYNGEAL SPACE INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PELVIC ABSCESS ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
PERIODONTITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PERITONSILLAR ABSCESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PNEUMOCYSTIS JIROVECII INFECTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PNEUMOCYSTIS JIROVECII PNEUMONIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PNEUMONIA ^† 1	43/692 (6.21%)	51	51/698 (7.31%)	61
PNEUMONIA BACTERIAL ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
PNEUMONIA FUNGAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PNEUMONIA PNEUMOCOCCAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
POST PROCEDURAL INFECTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PULMONARY SEPSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PYELONEPHRITIS ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
Q FEVER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RESPIRATORY TRACT INFECTION ^† 1	5/692 (0.72%)	11	6/698 (0.86%)	7
RHINITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
RHINOVIRUS INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SCROTAL ABSCESS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SEPSIS ^† 1	9/692 (1.30%)	9	14/698 (2.01%)	18
SEPTIC SHOCK ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
SINUSITIS ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
SINUSITIS BACTERIAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SINUSITIS FUNGAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SOFT TISSUE INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
STAPHYLOCOCCAL BACTERAEMIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
STAPHYLOCOCCAL INFECTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SUBCUTANEOUS ABSCESS ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
TUBERCULOSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
TUBO-OVARIAN ABSCESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
UPPER RESPIRATORY TRACT INFECTION ^† 1	3/692 (0.43%)	3	5/698 (0.72%)	7
URINARY TRACT INFECTION ^† 1	7/692 (1.01%)	7	8/698 (1.15%)	8
UROSEPSIS ^† 1	5/692 (0.72%)	6	4/698 (0.57%)	5
VARICELLA ZOSTER SEPSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
VASCULAR DEVICE INFECTION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
VIRAL INFECTION ^† 1	4/692 (0.58%)	4	1/698 (0.14%)	1
VIRAL MYOSITIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Injury, poisoning and procedural complications
ACCIDENT ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ALCOHOL POISONING ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ANASTOMOTIC STENOSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ANKLE FRACTURE ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
BRAIN CONTUSION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CARTILAGE INJURY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
COMPRESSION FRACTURE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
FACIAL BONES FRACTURE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
FALL ^† 1	1/692 (0.14%)	1	3/698 (0.43%)	3
FEMUR FRACTURE ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
FOOT FRACTURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HAND FRACTURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HUMERUS FRACTURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INFUSION RELATED REACTION ^† 1	19/692 (2.75%)	21	36/698 (5.16%)	42
LIGAMENT SPRAIN ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
LUMBAR VERTEBRAL FRACTURE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
MEDICATION ERROR ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MENISCUS INJURY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MULTIPLE FRACTURES ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PNEUMOTHORAX TRAUMATIC ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
POST PROCEDURAL HAEMORRHAGE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
SEROMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SPINAL COMPRESSION FRACTURE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
THORACIC VERTEBRAL FRACTURE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
UPPER LIMB FRACTURE ^† 1	4/692 (0.58%)	4	1/698 (0.14%)	1
Investigations
ALANINE AMINOTRANSFERASE INCREASED ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ASPARTATE AMINOTRANSFERASE INCREASED ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BLOOD CREATININE INCREASED ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HEPATIC ENZYME INCREASED ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
INTERNATIONAL NORMALISED RATIO INCREASED ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
RESPIROVIRUS TEST POSITIVE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
WHITE BLOOD CELLS URINE POSITIVE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Metabolism and nutrition disorders
DEHYDRATION ^† 1	2/692 (0.29%)	2	4/698 (0.57%)	4
DIABETES MELLITUS ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
FLUID OVERLOAD ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HYPERCALCAEMIA ^† 1	2/692 (0.29%)	2	2/698 (0.29%)	2
HYPERGLYCAEMIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HYPOKALAEMIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
HYPONATRAEMIA ^† 1	1/692 (0.14%)	1	4/698 (0.57%)	4
TUMOUR LYSIS SYNDROME ^† 1	1/692 (0.14%)	1	3/698 (0.43%)	3
Musculoskeletal and connective tissue disorders
ARTHROPATHY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BACK PAIN ^† 1	3/692 (0.43%)	4	2/698 (0.29%)	2
FLANK PAIN ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
HAEMARTHROSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
INTERVERTEBRAL DISC PROTRUSION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
MUSCULAR WEAKNESS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
MYOPATHY ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
MYOSITIS ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	2
NECK PAIN ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
OSTEITIS DEFORMANS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
OSTEOARTHRITIS ^† 1	3/692 (0.43%)	3	2/698 (0.29%)	3
PAIN IN EXTREMITY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PATHOLOGICAL FRACTURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ROTATOR CUFF SYNDROME ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SERONEGATIVE ARTHRITIS ^† 1	1/692 (0.14%)	2	0/698 (0.00%)	0
SPINAL PAIN ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SPINAL STENOSIS ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
SYNOVITIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
TEMPOROMANDIBULAR JOINT SYNDROME ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACOUSTIC NEUROMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ACUTE LYMPHOCYTIC LEUKAEMIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ACUTE MYELOID LEUKAEMIA ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	4
ADENOCARCINOMA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
ADENOCARCINOMA METASTATIC ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ADENOCARCINOMA OF COLON ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	3
BASAL CELL CARCINOMA ^† 1	3/692 (0.43%)	3	6/698 (0.86%)	7
BENIGN LARYNGEAL NEOPLASM ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BLADDER TRANSITIONAL CELL CARCINOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BLADDER TRANSITIONAL CELL CARCINOMA METASTATIC ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
BOWEN'S DISEASE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BREAST CANCER ^† 1	0/692 (0.00%)	0	6/698 (0.86%)	6
CANCER PAIN ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CHOLANGIOCARCINOMA ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
COLON CANCER ^† 1	3/692 (0.43%)	3	1/698 (0.14%)	1
COLORECTAL CANCER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
DUCTAL ADENOCARCINOMA OF PANCREAS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
GASTRIC ADENOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
GASTRIC CANCER ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
GASTROINTESTINAL NEOPLASM ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HEPATIC CANCER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HODGKIN'S DISEASE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HODGKIN'S DISEASE NODULAR SCLEROSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HODGKIN'S DISEASE STAGE II ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HORMONE RECEPTOR POSITIVE BREAST CANCER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
INTRADUCTAL PROLIFERATIVE BREAST LESION ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
INTRAOCULAR MELANOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
INVASIVE DUCTAL BREAST CARCINOMA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
KERATOACANTHOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
LARYNGEAL SQUAMOUS CELL CARCINOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
LENTIGO MALIGNA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
LUNG ADENOCARCINOMA ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
LUNG NEOPLASM MALIGNANT ^† 1	3/692 (0.43%)	3	0/698 (0.00%)	0
MALIGNANT MELANOMA ^† 1	3/692 (0.43%)	4	1/698 (0.14%)	1
MENINGIOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MYELODYSPLASTIC SYNDROME ^† 1	0/692 (0.00%)	0	4/698 (0.57%)	4
NEUROENDOCRINE CARCINOMA OF THE SKIN ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
NON-HODGKIN'S LYMPHOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
NON-SMALL CELL LUNG CANCER ^† 1	2/692 (0.29%)	2	2/698 (0.29%)	2
NON-SMALL CELL LUNG CANCER STAGE IV ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
OESOPHAGEAL CARCINOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PANCREATIC CARCINOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PAPILLARY THYROID CANCER ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
PITUITARY TUMOUR BENIGN ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PROSTATE CANCER ^† 1	4/692 (0.58%)	4	5/698 (0.72%)	5
RECTAL ADENOCARCINOMA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
RENAL CANCER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
RENAL CELL CARCINOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SCHWANNOMA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SQUAMOUS CELL BREAST CARCINOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SQUAMOUS CELL CARCINOMA ^† 1	1/692 (0.14%)	1	2/698 (0.29%)	2
SQUAMOUS CELL CARCINOMA OF SKIN ^† 1	2/692 (0.29%)	2	5/698 (0.72%)	5
THYROID ADENOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
TRANSITIONAL CELL CARCINOMA ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	4
TUMOUR FLARE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
UTERINE CANCER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
VULVOVAGINAL WARTS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ATAXIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
BRACHIAL PLEXOPATHY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CAROTID ARTERY STENOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CEREBRAL DISORDER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CEREBRAL HAEMATOMA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CEREBRAL INFARCTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CEREBRAL ISCHAEMIA ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
CEREBROVASCULAR ACCIDENT ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
DEMENTIA ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
DIZZINESS ^† 1	3/692 (0.43%)	3	1/698 (0.14%)	1
DIZZINESS POSTURAL ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DYSDIADOCHOKINESIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ENCEPHALOPATHY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
EPILEPSY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
FACIAL PARALYSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
HAEMORRHAGE INTRACRANIAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HAEMORRHAGIC STROKE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HYPERAMMONAEMIC ENCEPHALOPATHY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HYPOTONIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ISCHAEMIC STROKE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
LETHARGY ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
LOSS OF CONSCIOUSNESS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
MONOPARESIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
NERVOUS SYSTEM DISORDER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
NEURALGIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
NEUROPATHY PERIPHERAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
ORTHOSTATIC INTOLERANCE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ORTHOSTATIC TREMOR ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PARKINSON'S DISEASE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
POLYNEUROPATHY ^† 1	1/692 (0.14%)	2	0/698 (0.00%)	0
PRESYNCOPE ^† 1	3/692 (0.43%)	3	0/698 (0.00%)	0
SEIZURE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	2
SPINAL CORD COMPRESSION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SUBARACHNOID HAEMORRHAGE ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SYNCOPE ^† 1	3/692 (0.43%)	3	4/698 (0.57%)	4
TRANSIENT ISCHAEMIC ATTACK ^† 1	1/692 (0.14%)	1	5/698 (0.72%)	5
TREMOR ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
ABORTION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Product Issues
DEVICE BREAKAGE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Psychiatric disorders
ALCOHOL PROBLEM ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ANXIETY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CONFUSIONAL STATE ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
DELIRIUM ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DEPRESSION ^† 1	2/692 (0.29%)	2	3/698 (0.43%)	5
EMOTIONAL DISORDER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
MENTAL STATUS CHANGES ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
PSYCHOTIC DISORDER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
SUBSTANCE-INDUCED PSYCHOTIC DISORDER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
SUICIDE ATTEMPT ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY ^† 1	2/692 (0.29%)	2	4/698 (0.57%)	4
NEPHROLITHIASIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
RENAL COLIC ^† 1	1/692 (0.14%)	2	0/698 (0.00%)	0
RENAL FAILURE ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
RENAL INFARCT ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RENAL PAIN ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RENAL PELVIS FISTULA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
URETERIC OBSTRUCTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
Reproductive system and breast disorders
OVARIAN CYST ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
OVARIAN MASS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PROSTATITIS ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
VAGINAL ULCERATION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
VULVOVAGINAL PAIN ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE LUNG INJURY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ACUTE RESPIRATORY DISTRESS SYNDROME ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
ACUTE RESPIRATORY FAILURE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
ASTHMA ^† 1	2/692 (0.29%)	2	2/698 (0.29%)	2
BRONCHOSPASM ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1	3/692 (0.43%)	6	1/698 (0.14%)	1
COUGH ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
DYSPNOEA ^† 1	8/692 (1.16%)	8	10/698 (1.43%)	12
DYSPNOEA EXERTIONAL ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
EMPHYSEMA ^† 1	1/692 (0.14%)	2	1/698 (0.14%)	1
EPISTAXIS ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
HAEMOPTYSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HYPOXIA ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
INTERSTITIAL LUNG DISEASE ^† 1	4/692 (0.58%)	4	2/698 (0.29%)	2
LUNG CONSOLIDATION ^† 1	2/692 (0.29%)	2	0/698 (0.00%)	0
LUNG DISORDER ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PARANASAL CYST ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PHARYNGEAL INFLAMMATION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PHARYNGEAL PARAESTHESIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PLEURAL EFFUSION ^† 1	5/692 (0.72%)	5	5/698 (0.72%)	5
PLEURISY ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PLEURITIC PAIN ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
PNEUMONIA ASPIRATION ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
PNEUMONITIS ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
PNEUMOTHORAX ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PULMONARY ARTERIAL HYPERTENSION ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
PULMONARY CONGESTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PULMONARY EMBOLISM ^† 1	2/692 (0.29%)	2	8/698 (1.15%)	11
PULMONARY OEDEMA ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	2
RESPIRATORY ARREST ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
RESPIRATORY DISORDER ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RESPIRATORY FAILURE ^† 1	2/692 (0.29%)	2	3/698 (0.43%)	3
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
DERMATITIS CONTACT ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DERMATITIS EXFOLIATIVE GENERALISED ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DRUG ERUPTION ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
RASH ^† 1	2/692 (0.29%)	2	5/698 (0.72%)	5
RASH MACULO-PAPULAR ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
URTICARIA ^† 1	1/692 (0.14%)	1	1/698 (0.14%)	1
Vascular disorders
AXILLARY VEIN THROMBOSIS ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
CIRCULATORY COLLAPSE ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
DEEP VEIN THROMBOSIS ^† 1	2/692 (0.29%)	2	1/698 (0.14%)	1
EMBOLISM ^† 1	3/692 (0.43%)	3	0/698 (0.00%)	0
HYPERTENSIVE CRISIS ^† 1	0/692 (0.00%)	0	2/698 (0.29%)	3
HYPERTENSIVE URGENCY ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
HYPOTENSION ^† 1	2/692 (0.29%)	2	7/698 (1.00%)	7
PELVIC VENOUS THROMBOSIS ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PERIPHERAL ARTERY ANEURYSM ^† 1	1/692 (0.14%)	1	0/698 (0.00%)	0
PERIPHERAL ISCHAEMIA ^† 1	0/692 (0.00%)	0	1/698 (0.14%)	1
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rituximab+Chemotherapy		Obinutuzumab+Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	675/692 (97.54%)		690/698 (98.85%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	72/692 (10.40%)	95	75/698 (10.74%)	88
LEUKOPENIA ^† 1	91/692 (13.15%)	267	87/698 (12.46%)	222
NEUTROPENIA ^† 1	307/692 (44.36%)	777	348/698 (49.86%)	885
THROMBOCYTOPENIA ^† 1	52/692 (7.51%)	79	90/698 (12.89%)	150
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	78/692 (11.27%)	95	69/698 (9.89%)	84
ABDOMINAL PAIN UPPER ^† 1	53/692 (7.66%)	60	57/698 (8.17%)	64
CONSTIPATION ^† 1	221/692 (31.94%)	301	249/698 (35.67%)	326
DIARRHOEA ^† 1	168/692 (24.28%)	253	207/698 (29.66%)	318
DRY MOUTH ^† 1	23/692 (3.32%)	25	36/698 (5.16%)	40
DYSPEPSIA ^† 1	50/692 (7.23%)	56	65/698 (9.31%)	82
NAUSEA ^† 1	338/692 (48.84%)	577	354/698 (50.72%)	594
STOMATITIS ^† 1	55/692 (7.95%)	71	54/698 (7.74%)	72
VOMITING ^† 1	151/692 (21.82%)	211	182/698 (26.07%)	242
General disorders
ASTHENIA ^† 1	44/692 (6.36%)	55	47/698 (6.73%)	56
CHEST DISCOMFORT ^† 1	36/692 (5.20%)	43	43/698 (6.16%)	45
CHILLS ^† 1	74/692 (10.69%)	99	126/698 (18.05%)	172
FATIGUE ^† 1	277/692 (40.03%)	392	275/698 (39.40%)	390
INFLUENZA LIKE ILLNESS ^† 1	35/692 (5.06%)	36	34/698 (4.87%)	38
MUCOSAL INFLAMMATION ^† 1	44/692 (6.36%)	55	36/698 (5.16%)	41
OEDEMA PERIPHERAL ^† 1	40/692 (5.78%)	47	46/698 (6.59%)	50
PAIN ^† 1	35/692 (5.06%)	40	26/698 (3.72%)	28
PYREXIA ^† 1	150/692 (21.68%)	231	200/698 (28.65%)	277
Infections and infestations
BRONCHITIS ^† 1	42/692 (6.07%)	53	47/698 (6.73%)	69
CONJUNCTIVITIS ^† 1	26/692 (3.76%)	30	35/698 (5.01%)	42
HERPES ZOSTER ^† 1	40/692 (5.78%)	46	70/698 (10.03%)	75
LOWER RESPIRATORY TRACT INFECTION ^† 1	71/692 (10.26%)	105	59/698 (8.45%)	97
NASOPHARYNGITIS ^† 1	143/692 (20.66%)	224	135/698 (19.34%)	200
ORAL HERPES ^† 1	43/692 (6.21%)	48	46/698 (6.59%)	54
PNEUMONIA ^† 1	46/692 (6.65%)	59	47/698 (6.73%)	63
RESPIRATORY TRACT INFECTION ^† 1	35/692 (5.06%)	43	39/698 (5.59%)	67
RHINITIS ^† 1	36/692 (5.20%)	49	59/698 (8.45%)	71
SINUSITIS ^† 1	47/692 (6.79%)	58	68/698 (9.74%)	92
UPPER RESPIRATORY TRACT INFECTION ^† 1	132/692 (19.08%)	189	153/698 (21.92%)	217
URINARY TRACT INFECTION ^† 1	66/692 (9.54%)	100	75/698 (10.74%)	111
Injury, poisoning and procedural complications
INFUSION RELATED REACTION ^† 1	347/692 (50.14%)	569	416/698 (59.60%)	699
Investigations
WEIGHT DECREASED ^† 1	45/692 (6.50%)	49	35/698 (5.01%)	37
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	91/692 (13.15%)	103	98/698 (14.04%)	114
HYPOKALAEMIA ^† 1	29/692 (4.19%)	43	48/698 (6.88%)	72
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	127/692 (18.35%)	160	144/698 (20.63%)	180
BACK PAIN ^† 1	115/692 (16.62%)	143	99/698 (14.18%)	127
BONE PAIN ^† 1	44/692 (6.36%)	56	40/698 (5.73%)	46
MUSCLE SPASMS ^† 1	42/692 (6.07%)	49	40/698 (5.73%)	46
MYALGIA ^† 1	38/692 (5.49%)	43	53/698 (7.59%)	63
PAIN IN EXTREMITY ^† 1	65/692 (9.39%)	79	66/698 (9.46%)	75
Nervous system disorders
DIZZINESS ^† 1	57/692 (8.24%)	69	75/698 (10.74%)	88
DYSGEUSIA ^† 1	40/692 (5.78%)	44	38/698 (5.44%)	42
HEADACHE ^† 1	123/692 (17.77%)	185	155/698 (22.21%)	229
NEUROPATHY PERIPHERAL ^† 1	49/692 (7.08%)	52	51/698 (7.31%)	62
PARAESTHESIA ^† 1	51/692 (7.37%)	68	62/698 (8.88%)	71
PERIPHERAL SENSORY NEUROPATHY ^† 1	47/692 (6.79%)	50	59/698 (8.45%)	68
Psychiatric disorders
ANXIETY ^† 1	29/692 (4.19%)	31	44/698 (6.30%)	47
INSOMNIA ^† 1	89/692 (12.86%)	98	113/698 (16.19%)	131
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	185/692 (26.73%)	248	221/698 (31.66%)	305
DYSPNOEA ^† 1	88/692 (12.72%)	101	112/698 (16.05%)	131
OROPHARYNGEAL PAIN ^† 1	73/692 (10.55%)	87	82/698 (11.75%)	98
PRODUCTIVE COUGH ^† 1	35/692 (5.06%)	41	42/698 (6.02%)	53
THROAT IRRITATION ^† 1	37/692 (5.35%)	40	27/698 (3.87%)	27
Skin and subcutaneous tissue disorders
ALOPECIA ^† 1	77/692 (11.13%)	78	90/698 (12.89%)	94
DRY SKIN ^† 1	36/692 (5.20%)	39	40/698 (5.73%)	44
ERYTHEMA ^† 1	37/692 (5.35%)	43	37/698 (5.30%)	40
NIGHT SWEATS ^† 1	38/692 (5.49%)	46	32/698 (4.58%)	35
PRURITUS ^† 1	94/692 (13.58%)	116	102/698 (14.61%)	124
RASH ^† 1	131/692 (18.93%)	170	127/698 (18.19%)	162
Vascular disorders
FLUSHING ^† 1	40/692 (5.78%)	44	46/698 (6.59%)	56
HOT FLUSH ^† 1	25/692 (3.61%)	28	38/698 (5.44%)	43
HYPERTENSION ^† 1	50/692 (7.23%)	70	64/698 (9.17%)	100
HYPOTENSION ^† 1	28/692 (4.05%)	32	44/698 (6.30%)	48
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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):

Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.

Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.

Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.

Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.

Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.

Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. Erratum In: Lancet Oncol. 2019 Apr 29;:

Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.

Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01332968
Other Study ID Numbers:	BO21223 2010-024132-41 ( EudraCT Number )
First Submitted:	April 8, 2011
First Posted:	April 11, 2011
Results First Submitted:	February 3, 2017
Results First Posted:	June 7, 2017
Last Update Posted:	August 11, 2022

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