Study to Assess if ABP798 is Safe & Effective in Treating... | NCT02747043

ID	Type	Description	Link
2013-005542-11	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABP 798	Experimental	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.	Biological: ABP 798
Rituximab	Active Comparator	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.	Biological: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABP 798	Biological	ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease	Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria [Cheson et al, 1999]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.	Post treatment up to Week 28

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease	Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria [Cheson et al, 1999]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 18 years of age and older
Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization
Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
- subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization
- subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening.
Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria
- largest nodal or extranodal mass ≤ 7 cm
- no more than 3 nodal sites with diameter > 3 cm
- no splenomegaly > 16cm by CT scan and no symptomatic splenomegaly
- no significant pleural or peritoneal serous effusions by CT
- lactate dehydrogenase ≤ upper limit of normal (ULN)
- no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)

Exclusion Criteria:

Diffuse large cell component and/or Grade 3b follicular NHL
History or known presence of central nervous system metastases
Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)
Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)
Other investigational procedures that can impact the study data, results, or patient safety while participating in this study are excluded; participation in observational studies is allowed.
Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)
Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)
Systemic corticosteroid use within 3 months before randomization (inhaled are allowable)

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Encinitas	California	92024-1332	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
33044684	Derived	Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, Hanes V, Delwail V, Hajek R, Chien D. Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. Target Oncol. 2020 Oct;15(5):599-611. doi: 10.1007/s11523-020-00748-4.

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
FG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 17, 2017	Jun 26, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.6± 12.72 BG00158.2± 12.20 BG00257.9± 12.45

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<= 60 years	BG00071 BG00170 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00068 BG00162 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000102 BG001101 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Not Hispanic or Latino	BG000119 BG001119 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00075.29± 19.135 BG00175.19± 16.981 BG002

Height

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000166.81± 10.737 BG001167.64± 10.292 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status

Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Grade 0	BG000107 BG001

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Europe	BG00088 BG00186 BG002

Time Since Original Diagnosis

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	BG0006.31± 16.325 BG0015.17± 10.181 BG002

Previous Radiation Treatment

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG0003 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease

Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria [Cheson et al, 1999]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders.

CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results.

PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.

The modified full analysis set included all randomized participants with evidence of disease at baseline per the tumor assessment from the central, independent, blinded assessments. Analyses for the modified full analysis set was based on randomized treatment assignment.

Posted

Number

percentage of participants

Post treatment up to Week 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants	OG000123 OG001124

Title

Denominators

Categories

Title	Measurements
	OG00078.0(70.7 to 85.4) OG00170.2(62.1 to 78.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	7.7			2-Sided	90	-1.4	16.8			The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).		Equivalence	Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.

Secondary

Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease

CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results.

PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Secondary

Pharmacokinetic Serum Concentrations by Visit

Pharmacokinetic serum samples were analyzed by a central lab. Lower limit of quantification (LLOQ) was 0.25 ug/mL. PK concentrations below the lower limit of quantification were assigned a value of 0. Geometric mean and geometric CV were only calculated using concentrations >0.

Safety Analysis Set of participants with available data. Participants with PK concentrations below the lower limit of quantification (LLOQ) were excluded from these analyses.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/mL

Weeks 2, 3, 4, 12 and 20

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants

Secondary

Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8

Complete depletion of CD19+ cell count at any postdose time was defined as CD19+ cell counts < 20 cell/μL (0.02 * 10^9 cell/L). Participants with missing CD19+ cell count at baseline or participants with CD19+ cell count < 20 cell/μL at baseline were to be excluded from the derivation of complete depletion of CD19+ cell count.

Full analysis set of participants with available data. Participants with missing CD19+ cell count at baseline or participants with CD19+ cell count < 20 cell/μL at baseline were to be excluded from the derivation of complete depletion of CD19+ cell count.

Posted

Number

percentage of participants

Baseline (Day 1), Study Day 8

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts

Secondary

Total Immunoglobulin G (IgG) Results by Visit

Samples were analyzed by a central lab.

Full analysis set of participants with available data

Posted

Mean

Standard Deviation

g/L

Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants	OG000

Secondary

Total Immunoglobulin M (IgM) Results by Visit

Samples were analyzed by a central lab.

Full analysis set of participants with available data.

Posted

Mean

Standard Deviation

g/L

Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants	OG000

Secondary

Participants With Treatment-Emergent Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard.

IP = investigational product

Safety Analysis Set

Posted

Count of Participants

Participants

Day 1 (post treatment) to Week 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Secondary

Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)

The AEOIs prespecified for this study were infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, severe mucocutaneous reactions, tumor lysis syndrome, gastrointestinal perforation, and reversible posterior leukoencephalopathy syndrome.

Infusion reactions including hypersensitivity adverse events of interest must have start date the same as, or one day after, an investigational product administration start date.

Safety analysis set

Posted

Number

percentage of participants

Day 1 (post treatment) to Week 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants

Secondary

Number of Participants Who Developed Anti-drug Antibodies

Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay).

Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point.

Safety Analysis Set

Posted

Count of Participants

Participants

Baseline (Day 1), Weeks 12, 20 and 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants

Secondary

Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease

PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.

Safety Analysis Set

Posted

Number

percentage of participants

Day 1 up to Week 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Survived -- Overall Survival (OS)

Percentage of participants who were alive at the end of the study.

Safety Analysis Set

Posted

Number

percentage of participants

Day 1 up to Week 28

ID	Title	Description
OG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
OG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected128 at risk EG0010 affected126 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected128 at risk EG0011 affected126 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected128 at risk EG0019 affected126 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected128 at risk EG0019 affected126 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected128 at risk EG00114 affected126 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected128 at risk EG0016 affected126 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected128 at risk EG00112 affected126 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected128 at risk EG0018 affected126 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 affected128 at risk EG0011 affected126 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected128 at risk EG00112 affected126 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected128 at risk EG0018 affected126 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected128 at risk EG00112 affected126 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected128 at risk EG0016 affected126 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected128 at risk EG0012 affected126 at risk

ID	Term
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

ID	Term
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	Title	Description
BG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
BG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABP 798	ABP 798 was administered at a dose of 375 mg/m^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.	0	128	5	128	59	128
EG001	Rituximab	Rituximab was administered at a dose of 375 mg/m^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.	0	126	5	126	61	126