A Study of Subcutaneous Versus Intravenous MabThera/Ritux... | NCT01649856

NCT01649856

ID	Type	Description	Link
2012-000669-19	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
A: Rituximab SC	Experimental		Drug: CHOP Drug: rituximab [MabThera/Rituxan]
B: Rituximab IV	Active Comparator		Drug: CHOP Drug: rituximab [MabThera/Rituxan]

Name	Type	Description	Arm Group Labels	Other Names
CHOP	Drug	CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles	A: Rituximab SC B: Rituximab IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)	Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).	Up to approximately 4.25 years

Secondary Outcomes

Measure	Description	Time Frame
Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores	The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, >/= 18 and </= 80 years of age at time of study inclusion
Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion >/= 7.5 cm
At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
Adequate hematologic function
Eastern Cooperative Oncology Group (EOCD) performance status </= 2

Exclusion Criteria:

Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
Transformed lymphoma or follicular lymphoma IIIB
Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
Inadequate renal or hepatic function
Known human immunodeficiency virus (HIV) infection or HIV seropositive status
Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
Pregnant or lactating women

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward		Blida		09000	Algeria
Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28935843	Derived	Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rituximab Subcutaneous (SC)	Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Safety Population: All participants who received at least one dose of study drug according to treatment received.

Arm/Group Information

ID	Title	Description
BG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
BG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
BG002	Total	Total of all reporting groups

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
	OG00050.6(45.2 to 56.0) OG00142.4(35.0 to 50.0)

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		Chi-squared		0.076		Difference in Response Rates	8.2				95	-1.1	17.5					Superiority or Other

Secondary

Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores

The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.

ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.

Posted

Mean

Standard Deviation

units on a scale

At Cycle 7 (each cycle was 14 or 21 days)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV

Secondary

Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.

ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.

Posted

Mean

Standard Deviation

units on a scale

At Cycle 7 (each cycle was 14 or 21 days)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV

Secondary

Median Duration of Rituximab Administration for Each Treatment Cycle

Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.

Safety Population; n = number of participants in the analysis for the specified timepoint.

Posted

Median

Full Range

hours

Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle

Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as "Missing".

Safety Population.

Posted

Number

percentage of participants

Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle

Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".

Safety Population.

Posted

Number

percentage of participants

Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Number of Participants With an Event-Free Survival (EFS) Event

EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.

ITT Population.

Posted

Number

participants

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV

Secondary

Duration of EFS

EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.

ITT Population.

Posted

Median

Full Range

months

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV

Secondary

Number of Participants With Relapse or Death at the Time of Primary Analysis

Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.

ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.

Posted

Number

participants

Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001

Secondary

Duration of Disease-Free Survival (DFS)

DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.

ITT Population (Responder Subpopulation).

Posted

Median

Full Range

months

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Number of Participants With Progression, Relapse, or Death

Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.

ITT Population.

Posted

Number

participants

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Duration of Progression-Free Survival (PFS)

PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.

ITT Population.

Posted

Median

Full Range

months

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV

Secondary

Number of Deaths

ITT Population.

Posted

Number

participants

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

Secondary

Duration of Overall Survival (OS)

OS was defined as the time from randomization to death from any cause.

ITT Population.

Posted

Median

Full Range

months

Up to approximately 4.25 years

ID	Title	Description
OG000	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
OG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.

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	Rituximab SC	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.			155	369	319	369
EG001	Rituximab IV	Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.			77	203	172	203

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00049 affected369 at risk EG00124 affected203 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00022 affected369 at risk EG00110 affected203 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0012 affected203 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0013 affected203 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG00027 affected369 at risk EG0017 affected203 at risk
Septic shock	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected369 at risk EG0013 affected203 at risk
Lung infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0004 affected369 at risk EG0011 affected203 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Sepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0005 affected369 at risk EG0010 affected203 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Anal abscess	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Appendicitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Bronchiolitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Bronchitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Erysipelas	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
H1N1 influenza	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Herpes oesophagitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Herpes simplex hepatitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Herpes zoster	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Neutropenic infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Oral candidiasis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Oral herpes	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Peritonitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Sinusitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Tuberculosis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Viral infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected369 at risk EG0011 affected203 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected369 at risk EG0010 affected203 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Ileus	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Pyrexia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0007 affected369 at risk EG0013 affected203 at risk
Chills	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0012 affected203 at risk
Chest pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Death	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Fatigue	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
General physical health deterioration	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Influenza like illness	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Injection site hypertrophy	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Localised oedema	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Mucosal inflammation	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Oedema peripheral	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Sudden death	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0013 affected203 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0012 affected203 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0013 affected203 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0011 affected203 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0013 affected203 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0013 affected203 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0012 affected203 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Left ventricular failure	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Tachycardia induced cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Neutrophil count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected369 at risk EG0013 affected203 at risk
White blood cell count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Hepatic enzyme increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Troponin T increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Weight decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0011 affected203 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0011 affected203 at risk
Presyncope	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Cerebral infarction	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Dysarthria	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Embolism venous	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Flushing	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Hypotension	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Thrombosis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Adjustment disorder	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Anxiety	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Confusional state	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Proteinuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Intervertebral discitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Localised infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Ill-defined disorder	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0011 affected203 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Seizure	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Alanine aminotransferase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Blood bilirubin increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Platelet count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected369 at risk EG0010 affected203 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Arterial disorder	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Cytokine release syndrome	Immune system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected369 at risk EG0011 affected203 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected369 at risk EG0010 affected203 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG000104 affected369 at risk EG00154 affected203 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00088 affected369 at risk EG00140 affected203 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00079 affected369 at risk EG00147 affected203 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00056 affected369 at risk EG00134 affected203 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00052 affected369 at risk EG00120 affected203 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00040 affected369 at risk EG00117 affected203 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00023 affected369 at risk EG00111 affected203 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00024 affected369 at risk EG00112 affected203 at risk
Fatigue	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG00071 affected369 at risk EG00129 affected203 at risk
Pyrexia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG00040 affected369 at risk EG00123 affected203 at risk
Asthenia	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG00042 affected369 at risk EG00124 affected203 at risk
Mucosal inflammation	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG00029 affected369 at risk EG00116 affected203 at risk
Oedema peripheral	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG00027 affected369 at risk EG0019 affected203 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG00087 affected369 at risk EG00148 affected203 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00044 affected369 at risk EG00124 affected203 at risk
Paraesthesia	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00032 affected369 at risk EG00113 affected203 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG00021 affected369 at risk EG00115 affected203 at risk
Neutrophil count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG00081 affected369 at risk EG00143 affected203 at risk
Weight decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG00028 affected369 at risk EG0018 affected203 at risk
White blood cell count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG00051 affected369 at risk EG00123 affected203 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00042 affected369 at risk EG00119 affected203 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00022 affected369 at risk EG0016 affected203 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG00028 affected369 at risk EG00118 affected203 at risk
Insomnia	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG00023 affected369 at risk EG00113 affected203 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG00019 affected369 at risk EG00114 affected203 at risk
Lymphocyte count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG00053 affected369 at risk EG00120 affected203 at risk
Platelet count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG00019 affected369 at risk EG00111 affected203 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG00019 affected369 at risk EG0015 affected203 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG00018 affected369 at risk EG00111 affected203 at risk

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
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

ID	Term
D000069283	Rituximab

Ancestor Terms

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

Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.