Trial Outcomes & Findings for Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN) (NCT NCT04034056)

Last Updated: 2025-05-09

Results Overview

POD24=time from date of treatment initiation with obinutuzumab until first documented PD/death due to PD, whichever occurs first, within 24 months from start of treatment with obinutuzumab. According to standard Cheson criteria \& Deauville 5-point scale, PD=20% increase in sum of longest diameters (LD) of target lesions; for small lymph nodes measuring \<15 millimeters (mm) post therapy, a minimum absolute increase of 5 mm \& LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \& any 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) results. Participants with no PD \& who didn't die due to PD/were lost to follow-up at time of analysis were censored at date of last tumor assessment where no progression was documented/last date of follow-up for disease, whichever was last. Participants without post-baseline tumor assessments were censored at time of their baseline visit unless death due to PD occurred prior to their first scheduled tumor assessment.

Recruitment status

COMPLETED

Target enrollment

299 participants

Primary outcome timeframe

At Year 2

Results posted on

2025-05-09

Participant Flow

A total of 299 participants with untreated advanced follicular lymphoma (FL) took part in the study at 50 investigative sites in Italy from 02 September 2019 to 22 April 2024.

This was a prospective and retrospective data collection study. Participants were observed for safety and efficacy of obinutuzumab during the 6-month induction treatment with obinutuzumab and chemotherapy, and 24-month maintenance treatment with obinutuzumab monotherapy followed by 1 year of follow up.

Participant milestones

Participant milestones
Measure	Obinutuzumab Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Overall Study STARTED	299
Overall Study COMPLETED	228
Overall Study NOT COMPLETED	71

Reasons for withdrawal

Reasons for withdrawal
Measure	Obinutuzumab Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Overall Study Withdrawal by Subject	2
Overall Study Reason Not Specified	13
Overall Study Adverse Event	56

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Age, Continuous	60.8 years STANDARD_DEVIATION 10.4 • n=299 Participants
Sex: Female, Male Female	158 Participants n=299 Participants
Sex: Female, Male Male	141 Participants n=299 Participants

PRIMARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants with data available for POD24 analysis. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=281 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With Progression of Disease at Year 2 (POD24)	8.9 percentage of participants Interval 5.8 to 12.9

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With Progression-free Survival at Year 2 (PFS2)	85.6 percentage of participants Interval 81.1 to 89.4

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS at Year 3 (PFS3)	76.6 percentage of participants Interval 71.4 to 81.3

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.

TTNT was defined as the time to initiation of subsequent systemic anti-cancer therapy following initiation of obinutuzumab containing therapy. Participants who did not start subsequent systemic anti-cancer therapy were censored at the date of the last study visit.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Time to Next Treatment (TTNT)	1118 days Interval 167.0 to 1478.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.

OS was defined as the time from initiation of study treatment to death from any cause. Participants who were still alive at the time of analysis and participants who were lost to follow-up were censored at their last time known to be alive.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Overall Survival (OS)	1269 days Interval 1135.0 to 1277.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.

TTLCB was defined as the time from first dose to loss of clinical benefit as assessed by the treating physician (single or multiple reasons possible: e.g. PD, deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS), death, other). Participants who did not lose clinical benefit were censored at the date of the last study visit. Participants without post-baseline tumor assessments were censored at the time of their baseline visit unless death occurred prior to their first scheduled tumor assessment.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Time From First Dose to Loss of Clinical Benefit (TTLCB)	1127 days Interval 167.0 to 1266.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. Percentages have been rounded off.

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET. Per standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \& all nodes with long axis \< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \& no bone marrow involvement. PR was defined as ≥ 30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions and any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \> mediastinum but ≤ liver; 4=FDG uptake moderately \> liver; 5 (worst)=FDG uptake markedly \> than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Overall Response Rate (ORR) During Induction	95 percentage of participants Interval 91.2 to 97.5
Overall Response Rate (ORR) End of Induction	95.6 percentage of participants Interval 92.4 to 97.7
Overall Response Rate (ORR) During Maintenance	93.6 percentage of participants Interval 89.6 to 96.5
Overall Response Rate (ORR) End of Maintenance	94.3 percentage of participants Interval 89.5 to 97.4

SECONDARY outcome

Timeframe: Up to approximately 56 months

According to standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions and all nodes with long axis \< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. CR was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET results. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \> mediastinum but ≤ liver; 4=FDG uptake moderately \> liver; 5 (worst)=FDG uptake markedly \> than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With CR During Induction	35.9 percentage of participants Interval 29.6 to 42.6
Percentage of Participants With CR End of Induction	79.7 percentage of participants Interval 74.4 to 84.3
Percentage of Participants With CR During Maintenance	87.7 percentage of participants Interval 82.6 to 91.8
Percentage of Participants With CR End of Maintenance	90.6 percentage of participants Interval 84.9 to 94.6

SECONDARY outcome

Timeframe: At 30 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.

According to standard Cheson criteria and Deauville 5-point scale, CR at 30 months was defined as complete disappearance of all target lesions and all nodes with long axis \< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \> mediastinum but ≤ liver; 4=FDG uptake moderately \> liver; 5 (worst)=FDG uptake markedly \> than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With CR at 30 Months (CR30)	91 percentage of participants Interval 87.1 to 94.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed included participants with OR i.e responders. Different participants with responses at different timepoints during the study may have contributed to the summarized data.

DOR=time from first documentation of CR/PR until PD, as evaluated by physician according to routine clinical practice/death. CR=complete disappearance of all target lesions \& all nodes with long axis \<10 mm/ ≥30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \& no bone marrow involvement. PR= ≥30% decrease in sum of LD of target lesions but not CR; positive FDG-PET (Deauville score 4-5); no new lesions \& any bone marrow involvement. PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \<15 mm post therapy, minimum absolute increase of 5 mm \& LD should exceed 15 mm; appearance of new lesion; any bone marrow involvement \& FDG-PET results. Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1-5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤mediastinum; 3=FDG uptake \>mediastinum but ≤liver; 4=FDG uptake moderately \>liver; 5 (worst)=FDG uptake markedly \>than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=293 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Duration of Response (DOR)	1010 days Interval 73.0 to 1168.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.

TTR was defined as time from first dose of obinutuzumab to first documented response (CR or PR) as assessed in clinical routine. Per standard Cheson criteria \& Deauville 5-point scale, CR was defined as the complete disappearance of all target lesions and all nodes with long axis \< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. PR was defined as ≥30% decrease in the sum of LD of target lesions but not a CR (Deauville score 4-5); no new lesions \& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \> mediastinum but ≤ liver; 4=FDG uptake moderately \> liver; 5 (worst)=FDG uptake markedly \> than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Time to Response (TTR)	96 days Interval 15.0 to 577.0

SECONDARY outcome

Timeframe: Up to approximately 56 months

According to standard Cheson criteria and Deauville 5-point scale, SD was defined as \< 10% decrease or ≤ 20% increase in the sum of LD of target lesions; no new lesions; any bone marrow involvement and any FDG-PET results. SD was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months).

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With SD During Induction	2.3 percentage of participants Interval 0.7 to 5.2
Percentage of Participants With SD End of Induction	1.5 percentage of participants Interval 0.4 to 3.7
Percentage of Participants With SD During Maintenance	2.3 percentage of participants Interval 0.7 to 5.2
Percentage of Participants With SD End of Maintenance	1.9 percentage of participants Interval 0.4 to 5.4

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.

ORR was defined as percentage of participants with a CR/PR at end of induction \& maintenance therapy, as per clinical practice, with FDG-PET. According to standard Cheson criteria \& Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \& all nodes with long axis \< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \& no bone marrow involvement. PR was defined as ≥30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions \& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \> mediastinum but ≤ liver; 4=FDG uptake moderately \> liver; 5 (worst)=FDG uptake markedly \> than liver.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance End of Induction	95.6 percentage of participants Interval 92.4 to 97.7
Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance End of Maintenance	94.3 percentage of participants Interval 89.5 to 97.4

SECONDARY outcome

Timeframe: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)

Population: Safety population included all participants who were enrolled in the study.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Number of Participants With Adverse Events (AEs)	287 Participants

SECONDARY outcome

Timeframe: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)

Population: Safety population included all participants who were enrolled in the study.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any AE that meets any of the following criteria: is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study medicine and is a significant medical event in the physician's judgment.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Number of Participants With Serious Adverse Events (SAEs)	121 Participants

SECONDARY outcome

Timeframe: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)

Population: Safety population included all participants who were enrolled in the study.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESIs for this study may include the following: tumor lysis syndrome (TLS), irrespective of causality; second malignancies; cases of potential medicine-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law and suspected transmission of an infectious agent by the study medicine.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Number of Participants With Adverse Events of Special Interests (AESIs)	9 Participants

SECONDARY outcome

Timeframe: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)

Population: Safety population included all participants who were enrolled in the study.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=299 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Number of Participants With Infusion-related Reactions (IRRs)	38 Participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS=time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \& Deauville 5-point scale, PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \<15 mm post-therapy, a minimum absolute increase of 5 mm \& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \>60 years, Ann Arbor stage III-IV, hemoglobin (Hb) level \<12 grams per deciliter (gm/dL), \>4 nodal areas \& raised lactate dehydrogenase (LDH) levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 2 years, stratified by FLIPI score are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=254 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 0	0 percentage of participants
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 1	6.3 percentage of participants
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 2	37.4 percentage of participants
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 3	40.6 percentage of participants
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 4	12.6 percentage of participants
Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI) FLIPI Score 5	3.1 percentage of participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 2 years, stratified by ECOG-PS score are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=142 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 0	55.6 percentage of participants
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 1	40.8 percentage of participants
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 2	2.8 percentage of participants
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 3	0.7 percentage of participants
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 4	0 percentage of participants
Percentage of Participants With PFS2 Stratified by ECOG PS ECOG PS Score 5	0 percentage of participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=256 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by Age ≤ 60 Years	44.5 percentage of participants
Percentage of Participants With PFS2 Stratified by Age > 60 Years	55.5 percentage of participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 2 years, stratified by chemotherapy backbone are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=256 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice Bendamustine	47.3 percentage of participants
Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice CHOP	47.3 percentage of participants
Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice CVP	5.5 percentage of participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 2 years, stratified by positive \& negative HBV infection are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=230 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection Positive HBV	4.3 percentage of participants
Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection Negative HBV	95.7 percentage of participants

SECONDARY outcome

Timeframe: At Year 2

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=206 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Immune System Disorders	7 percentage of participants
Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Hepatobilliary Disorders	9.8 percentage of participants
Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Renal Disorders	4.3 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \& Deauville 5-point scale, PD was defined as 20% increase in sum of LD of target lesions; for small lymph nodes measuring \<15 mm post-therapy, a minimum absolute increase of 5 mm \& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \>60 years, Ann Arbor stage III-IV, Hb level \<12 gm/dL, \>4 nodal areas \& raised LDH levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 3 years, stratified by FLIPI score are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=227 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 0	0 percentage of participants
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 1	5.3 percentage of participants
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 2	39.6 percentage of participants
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 3	40.5 percentage of participants
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 4	11.5 percentage of participants
Percentage of Participants With PFS3 Stratified by FLIPI FLIPI Score 5	3.1 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 3 years, stratified by ECOG-PS score are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=126 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 0	57.1 percentage of participants
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 1	39.7 percentage of participants
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 2	3.2 percentage of participants
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 3	0 percentage of participants
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 4	0 percentage of participants
Percentage of Participants With PFS3 Stratified by ECOG PS ECOG PS Score 5	0 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=229 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by Age ≤ 60 Years	46.3 percentage of participants
Percentage of Participants With PFS3 Stratified by Age > 60 Years	53.7 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 3 years, stratified by chemotherapy backbone are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=229 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice Bendamustine	45.4 percentage of participants
Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice CHOP	48.9 percentage of participants
Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice CVP	5.7 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 3 years, stratified by positive \& negative HBV infection are presented.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=205 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by HBV Infection Positive HBV	4.4 percentage of participants
Percentage of Participants With PFS3 Stratified by HBV Infection Negative HBV	95.6 percentage of participants

SECONDARY outcome

Timeframe: At Year 3

Population: Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure.

PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 3 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Obinutuzumab n=182 Participants Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Immune System Disorders	7.4 percentage of participants
Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Hepatobilliary Disorders	8.7 percentage of participants
Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders Renal Disorders	4.4 percentage of participants

Adverse Events

Obinutuzumab

Serious events: 121 serious events

Other events: 113 other events

Deaths: 54 deaths

Serious adverse events

Serious adverse events
Measure	Obinutuzumab n=299 participants at risk Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Blood and lymphatic system disorders Febrile neutropenia	1.3% 4/299 • Number of events 4 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Blood and lymphatic system disorders Leukopenia	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Blood and lymphatic system disorders Lymphoma	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Blood and lymphatic system disorders Neutropenia	1.0% 3/299 • Number of events 5 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Blood and lymphatic system disorders Pancytopenia	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Cardiac disorders Atrial fibrillation	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Cardiac disorders Cardiac arrest	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Cardiac disorders Dyspnoea	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Cardiac disorders Myocardial infarction	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Cardiac disorders Pulmonary oedema	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Endocrine disorders Hyperparathyroidism	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Adenocarcinoma of colon	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Colon cancer	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Diarrhoea	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Intestinal ischaemia	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Large intestinal obstruction	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Malabsorption	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Gastrointestinal disorders Small intestinal obstruction	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
General disorders Multiple organ dysfunction syndrome	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
General disorders Pyrexia	1.7% 5/299 • Number of events 5 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Hepatobiliary disorders Bile duct stone	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Hepatobiliary disorders Cholangiocarcinoma	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Immune system disorders Interstitial lung disease	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Bronchiolitis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Coronavirus infection	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations COVID-19	17.1% 51/299 • Number of events 55 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations COVID-19 pneumonia	8.4% 25/299 • Number of events 31 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Cytomegalovirus infection reactivation	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Pneumonia	3.7% 11/299 • Number of events 11 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Post-acute COVID-19 syndrome	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Psoas abscess	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Respiratory tract infection	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Sepsis	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Septic shock	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Infections and infestations Staphylococcal sepsis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Injury, poisoning and procedural complications Femur fracture	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Injury, poisoning and procedural complications Hip fracture	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Injury, poisoning and procedural complications Humerus fracture	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Metabolism and nutrition disorders Acute respiratory failure	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Nervous system disorders Cerebral ischaemia	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Nervous system disorders Monoplegia	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Renal and urinary disorders Acute kidney injury	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Renal and urinary disorders Renal colic	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Renal and urinary disorders Renal failure	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Cough	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.67% 2/299 • Number of events 2 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pleural thickening	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 3/299 • Number of events 3 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Surgical and medical procedures Renal stone removal	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Surgical and medical procedures Ureteric calculus removal	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Surgical and medical procedures Uterine polypectomy	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Vascular disorders Deep vein thrombosis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Vascular disorders Haematoma	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Vascular disorders Jugular vein thrombosis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.
Vascular disorders Vena cava thrombosis	0.33% 1/299 • Number of events 1 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.

Other adverse events

Other adverse events
Measure	Obinutuzumab n=299 participants at risk Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).
Blood and lymphatic system disorders Neutropenia	37.8% 113/299 • Number of events 221 • All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months) Safety population included all participants who were enrolled in the study.

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