ECHELON-2: A Comparison of Brentuximab Vedotin and CHP Wi... | NCT01777152

NCT01777152

ID	Type	Description	Link
2012-002751-42	EudraCT Number

Status Module

Name	Class
Millennium Pharmaceuticals, Inc.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHOP	Active Comparator	cyclophosphamide, doxorubicin, vincristine, and prednisone	Drug: doxorubicin Drug: prednisone Drug: vincristine Drug: cyclophosphamide
A+CHP	Experimental	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone	Drug: brentuximab vedotin Drug: doxorubicin Drug: prednisone Drug: cyclophosphamide

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles	A+CHP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival Per Independent Review Facility (IRF)	The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.	Up to 60 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)	The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.	Up to 60 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Thomas Manley, MD	Seagen Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Gilbert	Arizona	85234	United States
City of Hope National Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40829107	Derived	Iyer S, Mehta-Shah N, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Alpdogan O, Feldman TA, Camus V, Gritti G, Zinzani PL, Belada D, Mayer J, Choi I, Cheong JW, Rustia E, Fenton K, Fanale M, Savage KJ, Horwitz SM. Association of PET4 response with outcomes of BV-CHP vs CHOP in the ECHELON-2 trial in CD30+ peripheral T-cell lymphoma. Blood Adv. 2025 Dec 9;9(23):5976-5987. doi: 10.1182/bloodadvances.2024015282.
40750774

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 12, 2018	Jun 6, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
BG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00058(18 to 85) BG00158(18 to 83) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00093 BG00175 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG00045 BG00154 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00070 BG00157 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status

0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead. One participant (ECOG=0) was assessed after start of treatment.

Count of Participants

Participants

Title

Denominators

Categories

Grade 0

Title	Measurements
	BG00085 BG001

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

Progression-free Survival Per Independent Review Facility (IRF)

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

Posted

Median

Inter-Quartile Range

months

Up to 60 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Units	Counts
Participants	OG000226 OG001226

Title

Denominators

Categories

Title	Measurements
	OG00048.20(8.87 to NA)Insufficient number of participants experienced events OG00120.80(4.70 to NA)Insufficient number of participants with events

Secondary

Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)

This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL).

Posted

Median

Inter-Quartile Range

months

Up to 60 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Secondary

Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)

The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

Posted

Count of Participants

Participants

Up to 8.34 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Secondary

Overall Survival (OS)

The time from randomization to death due to any cause.

The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

Posted

Median

Full Range

Months

Up to 90 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Units	Counts
Participants

Secondary

Objective Response Rate (ORR) Per IRF at End of Treatment

The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

Posted

Count of Participants

Participants

Up to 8.34 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Secondary

Incidence of Adverse Events (AEs)

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.

Posted

Count of Participants

Participants

Up to 8.28 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Secondary

Incidence of Laboratory Abnormalities

Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Posted

Count of Participants

Participants

Up to 8.28 months

ID	Title	Description
OG000	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
OG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Units

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	A+CHP	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	67	223	89	223	220	223
EG001	CHOP	cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	89	226	90	226	218	226
EG002	A+CHP Subgroup	Includes only participants in A+CHP arm who were randomized but did not receive treatment.	1	3	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00032 affected223 at risk EG00126 affected226 at risk EG0020 affected0 at risk
Pneumonia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00011 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected223 at risk EG0018 affected226 at risk EG0020 affected0 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0008 affected223 at risk EG0016 affected226 at risk EG0020 affected0 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0005 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0005 affected223 at risk EG0014 affected226 at risk EG0020 affected0 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Device related infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Neutropenic infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0016 affected226 at risk EG0020 affected0 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Abscess soft tissue	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Anal fistula infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Asthenia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Bacterial sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Cardiac arrest	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Dizziness	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Embolism	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Enterocolitis infectious	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Extravasation	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
H1N1 influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Haematuria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Hyperthermia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Hypotension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Injection site infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Lymph gland infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Mental status changes	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Mucosal inflammation	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0014 affected226 at risk EG0020 affected0 at risk
Non-cardiac chest pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Otitis externa	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Peripheral T-cell lymphoma unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Perirectal abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Renal failure	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Seizure	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Septic shock	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Soft tissue infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Staphylococcal infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Syncope	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Urinary retention	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Weight decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Anaplastic large cell lymphoma T- and null-cell types	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG00111 affected226 at risk EG0020 affected0 at risk
Arrhythmia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
CSF volume decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cerebral infarction	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Confusional state	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Death	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Device issue	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Erysipelas	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Escherichia sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Groin abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Hydrocephalus	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Laryngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0013 affected226 at risk EG0020 affected0 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Oliguria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Paraesthesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Skin infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected226 at risk EG0020 affected0 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Subileus	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Vertebral column mass	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Retinal vein occlusion	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Ulcerative gastritis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Diabetic foot infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Cutaneous T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0002 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected226 at risk EG0020 affected0 at risk
T-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected226 at risk EG0020 affected0 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00087 affected223 at risk EG00181 affected226 at risk EG0020 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00064 affected223 at risk EG00149 affected226 at risk EG0020 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00021 affected223 at risk EG00114 affected226 at risk EG0020 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00018 affected223 at risk EG00113 affected226 at risk EG0020 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00016 affected223 at risk EG0019 affected226 at risk EG0020 at risk
Hypothyroidism	Endocrine disorders	MedDRA (21.0)	Systematic Assessment	EG00012 affected223 at risk EG00111 affected226 at risk EG0020 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG000114 affected223 at risk EG00191 affected226 at risk EG0020 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00098 affected223 at risk EG00194 affected226 at risk EG0020 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00093 affected223 at risk EG00155 affected226 at risk EG0020 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00060 affected223 at risk EG00137 affected226 at risk EG0020 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00028 affected223 at risk EG00127 affected226 at risk EG0020 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected223 at risk EG00122 affected226 at risk EG0020 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00022 affected223 at risk EG00116 affected226 at risk EG0020 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00023 affected223 at risk EG00110 affected226 at risk EG0020 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00017 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0008 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Fatigue	General disorders	MedDRA (21.0)	Systematic Assessment	EG00083 affected223 at risk EG00180 affected226 at risk EG0020 at risk
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG00086 affected223 at risk EG00174 affected226 at risk EG0020 at risk
Oedema peripheral	General disorders	MedDRA (21.0)	Systematic Assessment	EG00040 affected223 at risk EG00136 affected226 at risk EG0020 at risk
Asthenia	General disorders	MedDRA (21.0)	Systematic Assessment	EG00035 affected223 at risk EG00120 affected226 at risk EG0020 at risk
Mucosal inflammation	General disorders	MedDRA (21.0)	Systematic Assessment	EG00015 affected223 at risk EG00114 affected226 at risk EG0020 at risk
Chest pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG00014 affected223 at risk EG0018 affected226 at risk EG0020 at risk
Malaise	General disorders	MedDRA (21.0)	Systematic Assessment	EG0008 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00018 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00010 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00012 affected223 at risk EG0019 affected226 at risk EG0020 at risk
Weight decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG00054 affected223 at risk EG00143 affected226 at risk EG0020 at risk
Alanine aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG00011 affected223 at risk EG0010 affected226 at risk EG0020 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00053 affected223 at risk EG00147 affected226 at risk EG0020 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00029 affected223 at risk EG00124 affected226 at risk EG0020 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00014 affected223 at risk EG00113 affected226 at risk EG0020 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00010 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected223 at risk EG00113 affected226 at risk EG0020 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00011 affected223 at risk EG0019 affected226 at risk EG0020 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00011 affected223 at risk EG0019 affected226 at risk EG0020 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00044 affected223 at risk EG00143 affected226 at risk EG0020 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00031 affected223 at risk EG00120 affected226 at risk EG0020 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00027 affected223 at risk EG00121 affected226 at risk EG0020 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00023 affected223 at risk EG00121 affected226 at risk EG0020 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00015 affected223 at risk EG00112 affected226 at risk EG0020 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00011 affected223 at risk EG0018 affected226 at risk EG0020 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG000112 affected223 at risk EG001108 affected226 at risk EG0020 at risk
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00037 affected223 at risk EG00136 affected226 at risk EG0020 at risk
Dizziness	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00032 affected223 at risk EG00124 affected226 at risk EG0020 at risk
Paraesthesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00013 affected223 at risk EG00119 affected226 at risk EG0020 at risk
Dysgeusia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00013 affected223 at risk EG00115 affected226 at risk EG0020 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0008 affected223 at risk EG00118 affected226 at risk EG0020 at risk
Insomnia	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00052 affected223 at risk EG00149 affected226 at risk EG0020 at risk
Anxiety	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00030 affected223 at risk EG00113 affected226 at risk EG0020 at risk
Depression	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00016 affected223 at risk EG00115 affected226 at risk EG0020 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected223 at risk EG00114 affected226 at risk EG0020 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00037 affected223 at risk EG00144 affected226 at risk EG0020 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00039 affected223 at risk EG00133 affected226 at risk EG0020 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00021 affected223 at risk EG00119 affected226 at risk EG0020 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00058 affected223 at risk EG00156 affected226 at risk EG0020 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00046 affected223 at risk EG00163 affected226 at risk EG0020 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00027 affected223 at risk EG00121 affected226 at risk EG0020 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00022 affected223 at risk EG00115 affected226 at risk EG0020 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00010 affected223 at risk EG00117 affected226 at risk EG0020 at risk
Hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG00071 affected223 at risk EG00168 affected226 at risk EG0020 at risk
Hypotension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG00015 affected223 at risk EG00114 affected226 at risk EG0020 at risk

Ancestor Terms

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
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
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
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Term
D017728	Lymphoma, Large-Cell, Anaplastic
D008228	Lymphoma, Non-Hodgkin
D016399	Lymphoma, T-Cell
D006402	Hematologic Diseases
D008223	Lymphoma

ID	Term
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
D004317	Doxorubicin
D011241	Prednisone
D014750	Vincristine
D003520	Cyclophosphamide