Study of Brentuximab Vedotin Combined With RCHOP or RCHP... | NCT01925612

Label	Type	Description	Intervention Names
Part 1: BV(1.2 mg/kg) + RCHOP	Experimental	Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.	Drug: brentuximab vedotin Drug: rituximab Drug: vincristine Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin
Part 1: BV(1.8 mg/kg) + RCHOP	Experimental	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.	Drug: brentuximab vedotin Drug: rituximab Drug: vincristine Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin
Part 2: BV(1.8 mg/kg) + RCHP	Experimental	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles	Part 1: BV(1.2 mg/kg) + RCHOP

Measure	Description	Time Frame
Complete Remission Rate	Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).	Up to 6 months
Incidence of Adverse Events	Number (count) of participants that experienced at least 1 adverse event.	Up to 6 months
Incidence of Laboratory Abnormalities	Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.	Up to 6 months

Measure	Description	Time Frame
Objective Response Rate	Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)	Up to 6 months
Progression-free Survival

Name	Affiliation	Role
Katherine Ruffner	Seagen Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology Associates, PC - HAL		Phoenix	Arizona	85016	United States
Arizona Oncology Associates, PC - HOPE

ID	Title	Description
FG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 10, 2015	Apr 18, 2018

Arm/Group Information

ID	Title	Description
BG000	Part 1: BV(1.2 mg/kg) + RCHOP	Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
BG001	Part 1: BV(1.8 mg/kg) + RCHOP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
BG002	Part 2: BV(1.8 mg/kg) + RCHP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
BG003	Part 3: BV(1.8 mg/kg) + RCHP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
BG004	Part 3: RCHOP	Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
BG005	Total	Total of all reporting groups

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

Complete Remission Rate

Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG002	Part 2: BV(1.8 mg/kg) + RCHP	Part 2 of the study was non-randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG003	Part 3: BV(1.8 mg/kg) + RCHP	Part 3 of the study was randomized and open-label. Brentuximab vedotin (1.8 mg/kg) was administered in combination with RCHP chemotherapy. brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG004	Part 3: RCHOP	Part 3 of the study was randomized and open-label. RCHOP chemotherapy was administered alone. rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Units	Counts
Participants	OG00029 OG00122 OG00211 OG003

Title

Denominators

Categories

Title	Measurements
	OG00020 OG00116 OG0029 OG003

Primary

Incidence of Adverse Events

Number (count) of participants that experienced at least 1 adverse event.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Primary

Incidence of Laboratory Abnormalities

Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Secondary

Objective Response Rate

Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Secondary

Progression-free Survival

Median progression-free survival (in months) and observed minimum-maximum range.

Posted

Median

Full Range

Months

Up to approximately 4 years

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Secondary

Overall Survival

Median overall survival (in months) and observed minimum-maximum range.

Posted

Median

Full Range

Months

Up to approximately 4 years

ID	Title	Description
OG000	Part 1: BV(1.2 mg/kg) + RCHOP	Part 1 of the study is randomized and open-label. Brentuximab vedotin was administered at 1.2mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
OG001	Part 1: BV(1.8 mg/kg) + RCHOP	Part 1 of the study is a randomized and open-label. Brentuximab vedotin was administered at 1.8 mg/kg in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

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	Part 1: BV(1.2 mg/kg) + RCHOP	Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles	1	29	16	29	29	29
EG001	Part 1: BV(1.8 mg/kg) + RCHOP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles	2	22	14	22	22	22
EG002	Part 2: BV(1.8 mg/kg) + RCHP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles	0	11	5	11	11	11
EG003	Part 3: BV(1.8 mg/kg) + RCHP	Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles	1	11	4	11	11	11
EG004	Part 3: RCHOP	Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles	2	12	4	12	12	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00013 events8 affected29 at risk EG00113 events8 affected22 at risk EG0022 events2 affected11 at risk EG0030 events0 affected11 at risk EG0042 events1 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Escherichia infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Pantoea agglomerans infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Cytomegalovirus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Platelet count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
White blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Guillain-barre syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Visual impairment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Stevens-johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00024 events14 affected29 at risk EG00123 events15 affected22 at risk EG0029 events8 affected11 at risk EG0036 events4 affected11 at risk EG0042 events2 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00019 events14 affected29 at risk EG00123 events15 affected22 at risk EG0024 events3 affected11 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 events8 affected29 at risk EG00112 events9 affected22 at risk EG0026 events6 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 events7 affected29 at risk EG00117 events14 affected22 at risk EG0022 events2 affected11 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 events8 affected29 at risk EG0014 events3 affected22 at risk EG0023 events3 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected29 at risk EG0013 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0022 events2 affected11 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected22 at risk EG0022 events2 affected11 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0022 events2 affected11 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected29 at risk EG0013 events3 affected22 at risk EG0022 events1 affected11 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0013 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Tongue discolouration	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected29 at risk EG00110 events9 affected22 at risk EG00210 events8 affected11 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events1 affected22 at risk EG0022 events2 affected11 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected29 at risk EG0012 events2 affected22 at risk EG0022 events2 affected11 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0022 events2 affected11 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected29 at risk EG0013 events3 affected22 at risk EG0022 events1 affected11 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG00028 events17 affected29 at risk EG00130 events16 affected22 at risk EG0027 events7 affected11 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG00019 events8 affected29 at risk EG0018 events7 affected22 at risk EG0020 events0 affected11 at risk EG003
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG00012 events7 affected29 at risk EG0014 events4 affected22 at risk EG0023 events3 affected11 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0009 events7 affected29 at risk EG0018 events7 affected22 at risk EG0022 events1 affected11 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0009 events6 affected29 at risk EG0016 events6 affected22 at risk EG0021 events1 affected11 at risk EG003
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected29 at risk EG0013 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0022 events1 affected11 at risk EG003
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00025 events16 affected29 at risk EG00127 events15 affected22 at risk EG0026 events6 affected11 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0007 events6 affected29 at risk EG0016 events6 affected22 at risk EG0025 events3 affected11 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected29 at risk EG0019 events8 affected22 at risk EG0021 events1 affected11 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00011 events4 affected29 at risk EG00114 events8 affected22 at risk EG0020 events0 affected11 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0006 events4 affected29 at risk EG0015 events5 affected22 at risk EG0022 events2 affected11 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected22 at risk EG0022 events2 affected11 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0024 events4 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0007 events7 affected29 at risk EG00112 events9 affected22 at risk EG0020 events0 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0017 events4 affected22 at risk EG0021 events1 affected11 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00010 events7 affected29 at risk EG00115 events10 affected22 at risk EG0022 events2 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG00111 events9 affected22 at risk EG0023 events2 affected11 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00010 events6 affected29 at risk EG0018 events5 affected22 at risk EG0021 events1 affected11 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0018 events5 affected22 at risk EG0020 events0 affected11 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0016 events2 affected22 at risk EG0021 events1 affected11 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Hyponatraemia	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG00111 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00027 events10 affected29 at risk EG00120 events7 affected22 at risk EG0025 events4 affected11 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00026 events9 affected29 at risk EG00120 events7 affected22 at risk EG0025 events2 affected11 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00020 events5 affected29 at risk EG00119 events3 affected22 at risk EG0022 events2 affected11 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00013 events2 affected29 at risk EG00116 events4 affected22 at risk EG0020 events0 affected11 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected29 at risk EG0014 events4 affected22 at risk EG0021 events1 affected11 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0007 events6 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected29 at risk EG0017 events4 affected22 at risk EG0020 events0 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0013 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected29 at risk EG0012 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Candida infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 events5 affected29 at risk EG0017 events5 affected22 at risk EG0022 events2 affected11 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected29 at risk EG0012 events2 affected22 at risk EG0021 events1 affected11 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0022 events1 affected11 at risk EG003
Fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0007 events7 affected29 at risk EG0018 events8 affected22 at risk EG0022 events2 affected11 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0015 events4 affected22 at risk EG0020 events0 affected11 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG00016 events10 affected29 at risk EG00113 events8 affected22 at risk EG0021 events1 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0023 events2 affected11 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
International normalised ratio increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected29 at risk EG0010 events0 affected22 at risk EG0022 events1 affected11 at risk EG003
White blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0022 events1 affected11 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0022 events2 affected11 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0019 events6 affected22 at risk EG0020 events0 affected11 at risk EG003
Flushing	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected29 at risk EG0010 events0 affected22 at risk EG0020 events0 affected11 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0009 events8 affected29 at risk EG0014 events4 affected22 at risk EG0020 events0 affected11 at risk EG003
Palpitations	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0015 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected22 at risk EG0021 events1 affected11 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected29 at risk EG0011 events1 affected22 at risk EG0020 events0 affected11 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected29 at risk EG0014 events3 affected22 at risk EG0020 events0 affected11 at risk EG003
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected29 at risk EG0012 events2 affected22 at risk EG0020 events0 affected11 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected22 at risk EG0021 events1 affected11 at risk EG003

ID	Term
D016393	Lymphoma, B-Cell
D016403	Lymphoma, Large B-Cell, Diffuse
D006402	Hematologic Diseases

ID	Term
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
D000079963	Brentuximab Vedotin
D000069283	Rituximab
D014750	Vincristine
D003520	Cyclophosphamide
D011241	Prednisone
D004317	Doxorubicin

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D058846	Antibodies, Monoclonal, Murine-Derived
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates