Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

Time frame: 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. IRRs were defined as all AEs that occurred during or within 24 hours after study treatment infusion and were judged to be related to infusion of study treatment.

Time frame: 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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: Up to approximately 56 months

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

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: Up to approximately 56 months

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

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 2 years, stratified by age (≤60 years & \>60 years) are presented.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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. Data for participants who were event-free at 2 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented.

Time frame: 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. Data for participants who were event-free at 3 years, stratified by age (≤60 years & \>60 years) are presented.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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. 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.

Time frame: 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; appearance of a new lesion; any bone marrow involvement & any FDG-PET results. Kaplan-Meier estimate of the PFS3 rate at 3 years (that is, the estimated percentage of participants with PFS3 at Year 3) is presented.

Time frame: 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.

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. Kaplan-Meier estimate of the PFS2 rate at 2 years (that is, the estimated percentage of participants with PFS2 at Year 2) is presented.

Time frame: 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.

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).

Time frame: 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.

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to approximately 56 months

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