Trial Outcomes & Findings for 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) (NCT NCT01332968)

Last Updated: 2022-08-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1401 participants

Primary outcome timeframe

Baseline up to data cut-off (up to approximately 4 years and 7 months)

Results posted on

2022-08-11

Participant Flow

The study was conducted at 177 centers in 18 countries.

Eleven participants withdrew from the study after randomization but prior to receiving study treatment.

Participant milestones

Participant milestones
Measure	Rituximab+Chemotherapy - Induction Period 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.	Obinutuzumab+Chemotherapy - Induction Period 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.	Rituximab+Chemotherapy - Maintenance 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.	Obinutuzumab+Chemotherapy - 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 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 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.	Rituximab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.	Obinutuzumab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.
Induction Period STARTED	699	702	0	0	0	0	0	0
Induction Period COMPLETED	641	646	0	0	0	0	0	0
Induction Period NOT COMPLETED	58	56	0	0	0	0	0	0
Maintenance/Observation Period STARTED	0	0	612	624	12	11	0	0
Maintenance/Observation Period COMPLETED	0	0	451	475	12	10	0	0
Maintenance/Observation Period NOT COMPLETED	0	0	161	149	0	1	0	0
Follow-Up Period STARTED	0	0	0	0	0	0	554	602
Follow-Up Period COMPLETED	0	0	0	0	0	0	324	367
Follow-Up Period NOT COMPLETED	0	0	0	0	0	0	230	235

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab+Chemotherapy - Induction Period 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.	Obinutuzumab+Chemotherapy - Induction Period 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.	Rituximab+Chemotherapy - Maintenance 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.	Obinutuzumab+Chemotherapy - 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.	Obinutuzumab+Chemotherapy - 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.	Rituximab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.	Obinutuzumab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.
Induction Period Adverse Event	23	26	0	0	0	0	0
Induction Period Death	1	4	0	0	0	0	0
Induction Period Non-compliance	1	0	0	0	0	0	0
Induction Period Other	2	2	0	0	0	0	0
Induction Period Physician Decision	6	1	0	0	0	0	0
Induction Period Progressive Disease	15	7	0	0	0	0	0
Induction Period Protocol Violation	3	4	0	0	0	0	0
Induction Period Withdrawal by Subject	3	5	0	0	0	0	0
Induction Period Randomised but not treated	4	7	0	0	0	0	0
Maintenance/Observation Period Adverse Event	0	0	53	66	0	0	0
Maintenance/Observation Period Death	0	0	5	6	0	0	0
Maintenance/Observation Period Lost to Follow-up	0	0	1	2	0	0	0
Maintenance/Observation Period Non-compliance	0	0	4	3	0	0	0
Maintenance/Observation Period Other	0	0	4	7	0	0	0
Maintenance/Observation Period Physician Decision	0	0	14	19	1	0	0
Maintenance/Observation Period Progressive Disease	0	0	72	40	0	0	0
Maintenance/Observation Period Protocol Violation	0	0	1	1	0	0	0
Maintenance/Observation Period Withdrawal by Subject	0	0	7	5	0	0	0
Follow-Up Period Adverse Event	0	0	0	0	0	0	4
Follow-Up Period Death	0	0	0	0	0	27	30
Follow-Up Period Lost to Follow-up	0	0	0	0	0	11	15
Follow-Up Period Non-compliance	0	0	0	0	0	4	9
Follow-Up Period Other	0	0	0	0	0	18	21
Follow-Up Period Physician Decision	0	0	0	0	0	12	15
Follow-Up Period Progressive Disease	0	0	0	0	0	126	106
Follow-Up Period Protocol Violation	0	0	0	0	0	1	0
Follow-Up Period Withdrawal by Subject	0	0	0	0	0	29	32
Follow-Up Period No reason provided	0	0	0	0	0	2	3

Baseline Characteristics

As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab+Chemotherapy - Induction Period n=699 Participants 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.	Obinutuzumab+Chemotherapy - Induction Period n=702 Participants 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 n=1401 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 12.3 • n=699 Participants	58.9 years STANDARD_DEVIATION 11.6 • n=702 Participants	58.5 years STANDARD_DEVIATION 11.9 • n=1401 Participants
Sex: Female, Male Female	374 Participants n=699 Participants	365 Participants n=702 Participants	739 Participants n=1401 Participants
Sex: Female, Male Male	325 Participants n=699 Participants	337 Participants n=702 Participants	662 Participants n=1401 Participants
Age Continuous in Follicular Lymphoma Sub-Population	57.7 years STANDARD_DEVIATION 12.2 • n=699 Participants	58.2 years STANDARD_DEVIATION 11.5 • n=702 Participants	57.9 years STANDARD_DEVIATION 11.9 • n=1401 Participants
Gender in Follicular Lymphoma Sub-Population Female	321 Participants n=601 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.	318 Participants n=601 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.	639 Participants n=1202 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.
Gender in Follicular Lymphoma Sub-Population Male	280 Participants n=601 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.	283 Participants n=601 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.	563 Participants n=1202 Participants • As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.

PRIMARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 4 years and 7 months)

Population: 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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed	24.0 percentage of participants with event	16.8 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to final analysis (up to 10 years)

Population: 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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed	40.6 percentage of participants with event	34.3 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Progression-Free Survival in the Overall Study Population, Investigator-Assessed	41.5 percentage of participants with event	34.8 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed	23.5 percentage of participants with event	18.0 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)	24.6 percentage of participants with event	18.4 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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 Response (Follicular Lymphoma Population), Investigator-Assessed Without PET	86.4 percentage of participants with event	88.2 percentage of participants with event
Overall Response (Follicular Lymphoma Population), Investigator-Assessed With PET	81.2 percentage of participants with event	85.5 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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 Response (Overall Study Population), Investigator-Assessed Without PET	85.7 percentage of participants with event	87.3 percentage of participants with event
Overall Response (Overall Study Population), Investigator-Assessed With PET	81.8 percentage of participants with event	85.4 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Complete Response (Follicular Lymphoma Population), Investigator-Assessed Without PET	24.1 percentage of participants with event	18.6 percentage of participants with event
Complete Response (Follicular Lymphoma Population), Investigator-Assessed With PET	56.7 percentage of participants with event	62.0 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Complete Response (Overall Study Population), Investigator-Assessed Without PET	23.3 percentage of participants with event	18.4 percentage of participants with event
Complete Response (Overall Study Population), Investigator-Assessed With PET	57.0 percentage of participants with event	61.1 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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 Response (Follicular Lymphoma Population), IRC-Assessed Without PET	88.0 percentage of participants with event	91.3 percentage of participants with event
Overall Response (Follicular Lymphoma Population), IRC-Assessed With PET	85.2 percentage of participants with event	88.6 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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 Response (Overall Study Population), IRC-Assessed Without PET	86.7 percentage of participants with event	89.9 percentage of participants with event
Overall Response (Overall Study Population), IRC-Assessed With PET	83.3 percentage of participants with event	87.2 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Complete Response (Follicular Lymphoma Population), IRC-Assessed Without PET	26.8 percentage of participants with event	28.5 percentage of participants with event
Complete Response (Follicular Lymphoma Population), IRC-Assessed With PET	59.7 percentage of participants with event	71.4 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to end of induction period (up to approximately 7 months)]

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Complete Response (Overall Study Population), IRC-Assessed Without PET	26.3 percentage of participants with event	27.1 percentage of participants with event
Complete Response (Overall Study Population), IRC-Assessed With PET	59.4 percentage of participants with event	69.5 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to 10 years

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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 Survival (Follicular Lymphoma Population)	14.3 percentage of participants with event	12.6 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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 Survival (Overall Study Population)	10.2 percentage of participants with event	8.4 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to 10 years

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Event-Free Survival (Follicular Lymphoma Population)	42.9 percentage of participants with event	35.8 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

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

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Event-Free Survival (Overall Study Population)	30.6 percentage of participants with event	22.6 percentage of participants with event

SECONDARY outcome

Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=330 Participants 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.	Obinutuzumab+Chemotherapy n=355 Participants 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.
Disease-Free Survival (Follicular Lymphoma Population)	27.9 percentage of participants with event	26.3 percentage of participants with event

SECONDARY outcome

Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=320 Participants 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.	Obinutuzumab+Chemotherapy n=343 Participants 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.
Disease-Free Survival (Overall Study Population)	14.9 percentage of participants with event	11.2 percentage of participants with event

SECONDARY outcome

Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=568 Participants 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.	Obinutuzumab+Chemotherapy n=571 Participants 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.
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed	39.3 percentage of participants with event	33.3 percentage of participants with event

SECONDARY outcome

Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)

Population: 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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=656 Participants 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.	Obinutuzumab+Chemotherapy n=659 Participants 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.
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed	25.5 percentage of participants with event	18.7 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to 10 years

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=601 Participants 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.	Obinutuzumab+Chemotherapy n=601 Participants 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.
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)	34.8 percentage of participants with event	26.6 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

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

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=699 Participants 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.	Obinutuzumab+Chemotherapy n=702 Participants 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.
Time to Next Anti-Lymphoma Treatment (Overall Study Population)	21.6 percentage of participants with event	15.7 percentage of participants with event

SECONDARY outcome

Timeframe: Baseline up to 10 years

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

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

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=692 Participants 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.	Obinutuzumab+Chemotherapy n=698 Participants 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.
Percentage of Participants With Adverse Events	99.6 percentage of participants	99.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=557 Participants 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.	Obinutuzumab+Chemotherapy n=566 Participants 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.
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) Physical Well-being (PW), Baseline	23.36 units on a scale Standard Deviation 4.77	23.14 units on a scale Standard Deviation 4.85
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) PW Change, Cycle 3, Day 1	-0.91 units on a scale Standard Deviation 4.54	-0.21 units on a scale Standard Deviation 4.59
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) PW Change, Maint Month 12	1.14 units on a scale Standard Deviation 4.29	1.34 units on a scale Standard Deviation 4.74
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) PW Change, End Maint	0.88 units on a scale Standard Deviation 4.54	1.33 units on a scale Standard Deviation 5.00
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) Social/Family Well-being , Baseline	22.84 units on a scale Standard Deviation 4.92	23.28 units on a scale Standard Deviation 4.77
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) S/FW Change, End Induction	-0.46 units on a scale Standard Deviation 4.77	-0.56 units on a scale Standard Deviation 5.00
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) S/FW Change, Maint Month 2	-0.39 units on a scale Standard Deviation 4.72	-0.67 units on a scale Standard Deviation 4.68
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) EW Change, Cycle 3 Day 1	1.49 units on a scale Standard Deviation 3.40	1.35 units on a scale Standard Deviation 3.35
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) EW Change, End Induction	1.16 units on a scale Standard Deviation 3.90	1.14 units on a scale Standard Deviation 3.87
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) EW Change, Maint Month 12	1.45 units on a scale Standard Deviation 3.92	1.46 units on a scale Standard Deviation 3.88
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) EW Change, End Maint	1.43 units on a scale Standard Deviation 3.98	1.49 units on a scale Standard Deviation 3.99
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) Functional Well-being (FW), Baseline	18.66 units on a scale Standard Deviation 6.19	18.76 units on a scale Standard Deviation 5.98
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) FW Change, End Induction	0.44 units on a scale Standard Deviation 5.63	0.93 units on a scale Standard Deviation 5.85
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) FW Change, End Maint	1.40 units on a scale Standard Deviation 6.12	1.72 units on a scale Standard Deviation 6.16
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) PW Change, End Induction	-0.06 units on a scale Standard Deviation 4.83	0.56 units on a scale Standard Deviation 5.14
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) PW Change, Maint Month 2	0.83 units on a scale Standard Deviation 4.76	1.42 units on a scale Standard Deviation 5.09
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) S/FW Change, Cycle 3 Day 1	-0.52 units on a scale Standard Deviation 4.03	-0.67 units on a scale Standard Deviation 3.92
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) S/FW Change, Maint Month 12	-0.61 units on a scale Standard Deviation 5.56	-0.97 units on a scale Standard Deviation 5.34
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) S/FW Change, End Maint	-0.93 units on a scale Standard Deviation 5.67	-0.71 units on a scale Standard Deviation 5.54
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) Emotional Well-being (EW), Baseline	17.64 units on a scale Standard Deviation 4.19	17.87 units on a scale Standard Deviation 4.13
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) EW Change, Maint Month 2	1.77 units on a scale Standard Deviation 3.88	1.49 units on a scale Standard Deviation 4.16
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) FW Change, Cycle 3 Day 1	-0.30 units on a scale Standard Deviation 5.30	-0.07 units on a scale Standard Deviation 5.24
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) FW Change, Maint Month 2	1.04 units on a scale Standard Deviation 5.31	1.25 units on a scale Standard Deviation 6.02
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) FW Change, Maint Month 12	1.84 units on a scale Standard Deviation 5.54	1.65 units on a scale Standard Deviation 5.95

SECONDARY outcome

Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=559 Participants 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.	Obinutuzumab+Chemotherapy n=567 Participants 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.
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score Change, Maint M12	7.61 units on a scale Standard Deviation 15.62	7.20 units on a scale Standard Deviation 16.75
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score, Baseline	86.61 units on a scale Standard Deviation 18.16	86.94 units on a scale Standard Deviation 18.05
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score Change, Cycle 3 Day 1	0.46 units on a scale Standard Deviation 15.03	2.18 units on a scale Standard Deviation 15.95
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score Change, End Induction	2.91 units on a scale Standard Deviation 17.00	4.57 units on a scale Standard Deviation 16.71
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score Change, Maint M2	6.22 units on a scale Standard Deviation 16.16	7.17 units on a scale Standard Deviation 16.57
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) TOI Score Change, End Maint	6.23 units on a scale Standard Deviation 17.06	7.44 units on a scale Standard Deviation 16.96

SECONDARY outcome

Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=556 Participants 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.	Obinutuzumab+Chemotherapy n=563 Participants 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.
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma Change, End Maint	4.31 units on a scale Standard Deviation 8.81	4.57 units on a scale Standard Deviation 8.54
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma, Baseline	45.01 units on a scale Standard Deviation 9.37	45.54 units on a scale Standard Deviation 9.29
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma Change, Cycle 3 Day 1	2.04 units on a scale Standard Deviation 7.18	2.71 units on a scale Standard Deviation 7.46
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma Change, End Induction	2.99 units on a scale Standard Deviation 8.63	3.01 units on a scale Standard Deviation 8.36
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma Change, Maint Month 2	4.80 units on a scale Standard Deviation 8.29	4.52 units on a scale Standard Deviation 8.32
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Lymphoma Change, Maint Month 12	4.93 units on a scale Standard Deviation 8.34	4.27 units on a scale Standard Deviation 8.31

SECONDARY outcome

Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=552 Participants 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.	Obinutuzumab+Chemotherapy n=559 Participants 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.
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score, Baseline	127.40 units on a scale Standard Deviation 22.43	128.42 units on a scale Standard Deviation 22.16
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score Change, Cycle 3 Day 1	1.98 units on a scale Standard Deviation 17.01	3.21 units on a scale Standard Deviation 17.12
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score Change, End Induction	4.18 units on a scale Standard Deviation 19.75	5.10 units on a scale Standard Deviation 20.03
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score Change, Maint Month 2	8.40 units on a scale Standard Deviation 19.16	8.13 units on a scale Standard Deviation 19.80
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score Change, Maint Month 12	8.87 units on a scale Standard Deviation 19.31	7.90 units on a scale Standard Deviation 19.55
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Total Score Change, End Maint	7.43 units on a scale Standard Deviation 19.88	8.80 units on a scale Standard Deviation 20.57

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=558 Participants 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.	Obinutuzumab+Chemotherapy n=559 Participants 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.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Change Baseline, Cycle 3 Day 1	0.03 units on a scale Standard Deviation 0.21	0.03 units on a scale Standard Deviation 0.20
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Change from Baseline, Maint/Obs Month 12	0.00 units on a scale Standard Deviation 0.00	-0.20 units on a scale Standard Deviation NA NA = NE = Not estimable based on 1 participant evaluated
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Change Baseline, Maint/Obs Completion	—	-0.10 units on a scale Standard Deviation NA NA = NE = Not estimable based on 1 participant evaluated
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Baseline Induction	0.80 units on a scale Standard Deviation 0.24	0.81 units on a scale Standard Deviation 0.21
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Change Baseline, Induction Compl	0.04 units on a scale Standard Deviation 0.23	0.03 units on a scale Standard Deviation 0.22
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Change Baseline, Maint/Obs Month 2	0.05 units on a scale Standard Deviation 0.23	0.06 units on a scale Standard Deviation 0.22

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=536 Participants 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.	Obinutuzumab+Chemotherapy n=547 Participants 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.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase Change Baseline, Maint/Obs Month 12	0.06 units on a scale Standard Deviation 0.24	0.06 units on a scale Standard Deviation 0.21
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase Change Baseline, Maint/Obs Completion	0.03 units on a scale Standard Deviation 0.23	0.05 units on a scale Standard Deviation 0.23
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase Change Baseline, Maint/Obs Month 2	0.04 units on a scale Standard Deviation 0.34	0.04 units on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Rituximab+Chemotherapy n=563 Participants 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.	Obinutuzumab+Chemotherapy n=564 Participants 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.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase Change Baseline, Follow-Up Month 36	0.05 units on a scale Standard Deviation 0.24	0.06 units on a scale Standard Deviation 0.23
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase Change Baseline, Follow-Up Month 48	0.05 units on a scale Standard Deviation 0.20	0.06 units on a scale Standard Deviation 0.23

Adverse Events

Rituximab+Chemotherapy

Serious events: 309 serious events

Other events: 675 other events

Deaths: 111 deaths

Obinutuzumab+Chemotherapy

Serious events: 361 serious events

Other events: 690 other events

Deaths: 104 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER