A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalid... | NCT02600897

ID	Type	Description	Link
2015-001999-22	EudraCT Number

Label	Type	Description	Intervention Names
Dose-escalation Cohort: FL	Experimental	Participants with R/R FL will receive 6 months of induction treatment with polatuzumab vedotin and lenalidomide at escalating doses to identify the recommended Phase 2 dose (RP2D) for polatuzumab vedotin and lenalidomide when combined with a fixed dose of obinutuzumab. Those who achieve CR, PR, or SD at the EOI (6-8 weeks after Day 1 of Cycle 6) will be eligible to receive a 24-month maintenance regimen consisting of lenalidomide and obinutuzumab, to be initiated 8 weeks after Day 1 of Cycle 6 (induction cycle).	Drug: Lenalidomide Drug: Obinutuzumab Drug: Polatuzumab Vedotin
Dose-escalation Cohort: DLBCL	Experimental	Participants with R/R DLBCL will receive 6 months of induction treatment with fixed dose of polatuzumab vedotin and rituximab along with dose escalating lenalidomide. Lenalidomide will be administered at escalating doses to identify the recommended Phase 2 dose (RP2D) for lenalidomide. Those who achieve CR and PR at the EOI (6-8 weeks after Day 1 of Cycle 6) will be eligible to receive a 6-month consolidation regimen consisting of lenalidomide and rituximab, to be initiated 8 weeks after Day 1 of Cycle 6 (induction cycle).	Drug: Lenalidomide Drug: Polatuzumab Vedotin Drug: Rituximab
Expansion Cohort: FL	Experimental	Participants with R/R FL who received induction treatment with polatuzumab vedotin and lenalidomide, in addition to obinutuzumab and achieved CR, PR, or SD at the EOI (6-8 weeks after Day 1 of Cycle 6) will receive a 24-months maintenance regimen consisting of lenalidomide and obinutuzumab for first 12 months followed by obinutuzumab treatment for next 12 months. Post-induction therapy will start 8 weeks after Cycle 6 Day 1.

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	All participants will receive lenalidomide oral capsules at doses of 10, 15, or 20 milligrams (mg) on Days 1 to 21 of each 28-day cycle for up to 6 Cycles in dose escalation phase followed by post-induction treatment at a dose of 10 mg once daily on Days 1 to 21 of each subsequent 28-day cycle. Post-induction lenalidomide may continue for up to 12 months until disease progression or unacceptable toxicity for participants with R/R FL and up to 6 months until disease progression or unacceptable toxicity for participants with R/R DLBCL.

Measure	Description	Time Frame
Percentage of Participants With Dose-Limiting Toxicities (DLTs)	A DLT was defined as any one of the following toxicities occurring during the first cycle of treatment and assessed by the investigator as related to study treatment: Any adverse event of any grade that lead to a delay of > 14 days in the start of the next treatment cycle, Grade 3 or 4 non-hematologic adverse events with few exceptions; increase in hepatic transaminase > 3 x baseline and an increase in direct bilirubin > 2 x upper limits of normal (ULN), without any findings of cholestasis or jaundice, or signs of hepatic dysfunction, and in the absence of other contributory factors; hematologic adverse events that met a few protocol specified criteria. DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Percentages have been rounded off to the first decimal point.	Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase
Percentage of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Percentages have been rounded off to the first decimal point.	From study start up to end of study (Up to a maximum of 69 months)
Percentage of Participants With Complete Response (CR) at End of Induction (EOI), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans	CR at EOI was assessed by IRC according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Measure	Description	Time Frame
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans	CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital		Marietta	Georgia	30060	United States

PubMed Identifier	Type	Citation	Retractions
38190832	Derived	Abrisqueta P, Gonzalez-Barca E, Panizo C, Perez JMA, Miall F, Bastos-Oreiro M, Triguero A, Banerjee L, McMillan A, Seymour E, Hirata J, de Guzman J, Sharma S, Jin HY, Musick L, Diefenbach C. Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study. Lancet Haematol. 2024 Feb;11(2):e136-e146. doi: 10.1016/S2352-3026(23)00345-9. Epub 2024 Jan 5.
34826412

ID	Title	Description
FG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 milligrams (mg) capsules orally once daily (QD) on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as intravenous (IV) infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 milligrams per kilogram (mg/kg), IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 19, 2017

Arm/Group Information

ID	Title	Description
BG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
BG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
BG002	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
BG003	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
BG004	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.
BG005	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.
BG006	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.
BG007	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
BG008	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.
BG009	Total	Total of all reporting groups

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Analyses

Primary

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

A DLT was defined as any one of the following toxicities occurring during the first cycle of treatment and assessed by the investigator as related to study treatment: Any adverse event of any grade that lead to a delay of > 14 days in the start of the next treatment cycle, Grade 3 or 4 non-hematologic adverse events with few exceptions; increase in hepatic transaminase > 3 x baseline and an increase in direct bilirubin > 2 x upper limits of normal (ULN), without any findings of cholestasis or jaundice, or signs of hepatic dysfunction, and in the absence of other contributory factors; hematologic adverse events that met a few protocol specified criteria. DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Percentages have been rounded off to the first decimal point.

The safety-evaluable population included all participants who received at least one dose of any component of the combination.

Posted

Number

percentage of participants

Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG002	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

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Title	Measurements
	OG0000.0 OG00150.0 OG0020.0 OG003

Primary

Percentage of Participants With Adverse Events (AEs)

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

The safety-evaluable population included all participants who received at least one dose of any component of the combination.

Posted

Number

percentage of participants

From study start up to end of study (Up to a maximum of 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Primary

Percentage of Participants With Complete Response (CR) at End of Induction (EOI), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans

CR at EOI was assessed by IRC according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms & those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans

CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake > mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone

CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in longest transverse diameter (LDi) and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone

CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans

OR was defined as percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT is complete MR in lymph nodes & ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake> mediastinum but ≤ liver; 4=uptake moderately > liver; 5=uptake markedly higher than liver and/or new lesions;no new lesions & no evidence of FDG-avid disease in bone marrow.Bone marrow is normal by morphology; if indeterminate, IHC negative. Partial response (PR) based on PET-CT was defined as partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages have been rounded off up to the second decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (cycle=28 days) (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Secondary

Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans

OR was defined percentage of participants with CR or PR assessed by the investigator according to MLRC. Per MLRC CR based on PET-CT is complete MR in lymph nodes & ELS with score of 1, 2, 3 with or without residual mass on 5PS, where 1=no uptake above background 2=uptake ≤ mediastinum 3=uptake> mediastinum but ≤ liver 4=uptake moderately > liver 5=uptake markedly higher than liver and/or new lesions;no new lesions & no evidence of FDG-avid disease in bone marrow.Bone marrow is normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes & ELS with score of 4 or 5 with reduced uptake compared with baseline & residual masses of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline(diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages are rounded off.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Percentage of Participants With Objective Response at EOI, Determined by the IRC on the Basis of CT Scans Alone

OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 28 days). Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Secondary

Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone

OR was defined as the percentage of participants with CR or PR, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Secondary

Percentage of Participants With Best Response of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone

BOR=CR/PR per CT per MLRC. Per MLRC, CR based on CT was defined as a complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. Percentages have been rounded off to the first decimal point.

Posted

Number

90% Confidence Interval

percentage of participants

Up to every 6 months until disease progression, unacceptable toxicity or study completion (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Observed Serum Obinutuzumab Concentration

1 cycle = 28 days

The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable postdose PK sample. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (μg/mL)

Day 1 of Cycles 1, 2, 4 & 6: predose & 30 mins postdose; EOI: predose; Day 1 of Maintenance Months 1,7, 13, 19;Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Observed Serum Rituximab Concentration

The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Day 1 of Cycles 1, 2, 4, 6: predose and 30 mins post-dose (1 cycle = 28 days) (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.

Secondary

Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Day 1 of Cycles 1, 2, 4: predose (1 cycle = 28 days), Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Secondary

Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE)

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliter (ng/mL)

Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1; Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Secondary

Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1 and Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Secondary

Observed Plasma Lenalidomide Concentration

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 1 Cycle 1: predose and 2 hours (hr) post-dose; Day 15 Cycle 1: predose, 0.5hr, 1hr, 2hr, 4hr, 8hr post-dose; Day 1 Cycle 6: 2hr post-dose; unscheduled visits: 2hr post-dose (1 cycle = 28 days) (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
OG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Secondary

Number of Participants With Human Anti-human Antibodies (HAHAs) to Obinutuzumab

The number of participants with positive results for HAHAs, also called anti-drug antibodies (ADAs) against obinutuzumab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Immunogenicity population included all safety-evaluable participants with at least one ADA Sample. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Count of Participants

Participants

Baseline up to approximately 2 years after last dose (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Secondary

Number of Participants With Human Anti-chimeric Antibodies (HACAs) to Rituximab

The number of participants with positive results for HACAs, also called ADAs against rituximab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.

Posted

Count of Participants

Participants

Baseline up to approximately 2 years after last dose (up to approximately 69 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.

Secondary

Number of Participants With Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin

The number of participants with positive results for ATAs, also called ADAs against polatuzumab vedotin at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.

Immunogenicity population included all safety-evaluable participants with at least one ADA sample. Due to missing baseline or post-baseline results not every participant was evaluable for baseline prevalence or post-baseline incidence of ADAs. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Count of Participants

Participants

Baseline up to approx. 2 years after the last dose of polatuzumab vedotin (up to approximately 30 months)

ID	Title	Description
OG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	1	3	3	3	3	3
EG001	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months	2	4	2	4	4	4
EG002	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	1	3	2	3	3	3
EG003	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	2	6	3	6	6	6
EG004	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.	3	3	0	3	3	3
EG005	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.	2	5	0	5	5	5
EG006	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.	10	10	4	10	9	10
EG007	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	7	40	26	40	40	40
EG008	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m^2 IV on Day 1 of every other month for up to 6 months.	20	39	19	39	37	39

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0022 events1 affected3 at risk EG0030 events0 affected6 at risk EG004
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PERICARDITIS	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
VISION BLURRED	Eye disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LIP SWELLING	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PYREXIA	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BRONCHIOLITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CELLULITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
COVID-19	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
EPIDIDYMITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INJECTION SITE INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LUNG ABSCESS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SEPSIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BRAIN STEM STROKE	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ENCEPHALOPATHY	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SEIZURE	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
STEVENS-JOHNSON SYNDROME	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0022 events1 affected3 at risk EG0035 events3 affected6 at risk EG0041 events1 affected3 at risk EG0053 events2 affected5 at risk EG0065 events5 affected10 at risk EG00729 events18 affected40 at risk EG00822 events14 affected39 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0019 events2 affected4 at risk EG0028 events1 affected3 at risk EG003
NEUTROPHILIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0023 events1 affected3 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TYMPANIC MEMBRANE PERFORATION	Ear and labyrinth disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DIABETES INSIPIDUS	Endocrine disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DRY EYE	Eye disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
OCULAR HYPERAEMIA	Eye disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PERIORBITAL OEDEMA	Eye disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
VISION BLURRED	Eye disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
DENTAL CARIES	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0003 events2 affected3 at risk EG0012 events2 affected4 at risk EG0023 events2 affected3 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
MELAENA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0012 events1 affected4 at risk EG0022 events2 affected3 at risk EG003
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
ASTHENIA	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0021 events1 affected3 at risk EG003
CHILLS	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
FATIGUE	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected4 at risk EG0022 events2 affected3 at risk EG003
FEELING ABNORMAL	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PAIN	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PERIPHERAL SWELLING	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PYREXIA	General disorders	MedDRA version: 24.1	Systematic Assessment	EG0003 events2 affected3 at risk EG0010 events0 affected4 at risk EG0026 events2 affected3 at risk EG003
OCULAR ICTERUS	Hepatobiliary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CYTOKINE RELEASE SYNDROME	Immune system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CANDIDA INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CONJUNCTIVITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INFLUENZA	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
ORAL CANDIDIASIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
RHINITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SINUSITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TONSILLITIS	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
UPPER RESPIRATORY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
AMYLASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
BLOOD GLUCOSE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BLOOD LACTATE DEHYDROGENASE DECREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CARDIAC STRESS TEST ABNORMAL	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
CREATININE RENAL CLEARANCE DECREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
CREATININE RENAL CLEARANCE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
IMMUNOGLOBULINS DECREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
LIPASE INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
GOUT	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events1 affected4 at risk EG0023 events1 affected3 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0022 events1 affected3 at risk EG003
HYPOPROTEINAEMIA	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
DIASTASIS RECTI ABDOMINIS	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SACRAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
BURNING SENSATION	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HEAD TITUBATION	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
HEADACHE	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0022 events1 affected3 at risk EG003
NEURALGIA	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RESTING TREMOR	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
VULVOVAGINAL DRYNESS	Reproductive system and breast disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
UPPER-AIRWAY COUGH SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
DYSHIDROTIC ECZEMA	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0003 events2 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
FLUSHING	Vascular disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version: 24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003

ID	Term
D012008	Recurrence
D008224	Lymphoma, Follicular
D016403	Lymphoma, Large B-Cell, Diffuse

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016393	Lymphoma, B-Cell

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Term
D000077269	Lenalidomide
C543332	obinutuzumab
C000600736	polatuzumab vedotin
D000069283	Rituximab