Brentuximab Vedotin and Combination Chemotherapy in Treat... | NCT01476410

NCT01476410

ID	Type	Description	Link
NCI-2011-00684	Registry Identifier	CTRP (Clinical Trial Reporting Program)
STU00046908	Other Identifier	Northwestern University IRB

Status Module

Sponsor/Collaborators Module

Name	Class
Robert H. Lurie Cancer Center	OTHER
Seagen 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
Treatment (antibody-drug conjugate and combination chemo)	Experimental	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.	Drug: brentuximab vedotin Drug: doxorubicin hydrochloride Drug: vinblastine Drug: dacarbazine Procedure: quality-of-life assessment Genetic: DNA analysis Genetic: RNA analysis Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Other: laboratory biomarker analysis Other: immunohistochemistry staining method Genetic: polymorphism analysis

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	Given IV	Treatment (antibody-drug conjugate and combination chemo)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Remission Rate After Chemotherapy	The primary objective of this study is to evaluate the complete remission rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy	after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate After 2 Cycles of SGN-35	The incidence of overall response rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed.	2 cycles of SGN-35 lead-in therapy, approximately 42 days
Complete Remission Rate Following 2 Cycles of SGN-35

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible
Stage II, III, and IV disease by Ann Arbor classification
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration
Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration
Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 45%
Absolute neutrophil count (ANC) > 1000/mm^3
Platelet count > 75,000/mm^3
Creatinine < 2.5 mg/dl
Bilirubin < 3.0 mg/dl
Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters
Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma
Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Patients must sign the informed consent form before registration

Exclusion Criteria:

Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy
History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])
Known cerebral/meningeal disease
Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally [po] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended
Patients with a known hypersensitivity to any excipient contained in the drug formulation
Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent

Contacts/Locations Module

Name	Affiliation	Role
Leo Gordon, MD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Stanford	California	94305	United States
NorthwesternU

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30179569	Derived	Evens AM, Advani RH, Helenowski IB, Fanale M, Smith SM, Jovanovic BD, Bociek GR, Klein AK, Winter JN, Gordon LI, Hamlin PA. Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma. J Clin Oncol. 2018 Oct 20;36(30):3015-3022. doi: 10.1200/JCO.2018.79.0139. Epub 2018 Sep 4.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 4, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

anti-CD30 ADC SGN-35

anti-CD30 antibody-drug conjugate SGN-35

antibody-drug conjugate SGN-35

Total enrollment was 49. 1 patient withdrew consent prior to starting treatment and is excluded.

Arm/Group Information

ID	Title	Description
BG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

60-70 years

Title	Measurements
	BG00025

71-80 years

Title	Measurements
	BG00015

>80 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018
Male	BG00030

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001
Not Hispanic or Latino	BG00043

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Histology

Count of Participants

Participants

Title

Denominators

Categories

Nodular Sclerosis

Title	Measurements
	BG00022

Mixed Cellularity

Title	Measurements
	BG000

ECOG Performance Score

ECOG PERFORMANCE STATUS

0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5 = Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00019

Presence of B symptoms?

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00018

Title	Measurements
	BG000

Albumin less than 4.0 g/dL

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00022

Title	Measurements
	BG000

International Prognostic Score

The International Prognostic Score (IPS) is the most widely used risk stratification index for Hodgkin's lymphoma (HL). There are seven factors that contribute to the IPS score: Age, Albumin Value, White Blood Cell Count, Hemoglobin, Lymphocyte Count, Sex, and Cancer Stage. The score ranges from 0-7. Each factor contributes one point to the overall score. A higher score indicates a poorer prognosis for overall survival.

Count of Participants

Participants

Title

Denominators

Categories

0-2

Title	Measurements
	BG00020

3-7

Title	Measurements

Bone Marrow Involvement

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00011

Title	Measurements
	BG000

Bulky Disease (greater than or equal to 10 cm)

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0005

Title	Measurements
	BG000

Hodgkin's Lymphoma Stage

Hodgkin's Lymphoma Staging

I = Localized disease, single lymph node region or single organ
II = Two or more lymph node regions on the same side of diaphragm
III = Two or more lymph node regions above and below the diaphragm
IV = Widespread disease; multiple organs, with or without lymph node involvement

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0009

III

Title	Measurements

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 After Chemotherapy

The primary objective of this study is to evaluate the complete remission rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy

6 patients did not complete the 2 lead-in doses of SGN-35 and 3 cycles of AVD and are therefore not evaluable

Posted

Count of Participants

Participants

after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 months

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Units	Counts
Participants	OG00042

Title

Denominators

Categories

Title	Measurements
	OG00038

Secondary

Overall Response Rate After 2 Cycles of SGN-35

The incidence of overall response rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed.

Posted

Count of Participants

Participants

2 cycles of SGN-35 lead-in therapy, approximately 42 days

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Complete Remission Rate Following 2 Cycles of SGN-35

The incidence of CR rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed

Posted

Count of Participants

Participants

2 cycles of lead-in SGN-35, approximately 42 days

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Safety of Sequential SGN-35/AVD/SGN-35 Therapy

Detailed examination of Averse Events, laboratory test results, vital signs or other physical findings. Below we have summarized the top 10 most common Grade 3 and Grade 4 related adverse events. Please see the Adverse Events section of this record for a full listing of Adverse Events.

Posted

Number

participants

From time of treatment to 30 days after discontinuation of study treatment

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

2-year Progression Free Survival

Progression Free Survival (PFS) is defined as lymphoma progression or death from any cause. This outcome measure is the percentage of patients that have not progressed at 2 years from time of registration.

Posted

Number

95% Confidence Interval

percentage of patients

2 years from time of registration to study

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Overall Survival Following SGN-35/AVD Sequential Therapy

Defined as the percentage of patients that are alive 2 years after registration.

Posted

Number

95% Confidence Interval

percentage of patients

up to 2 years from the time of registration

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Units

Secondary

2 Year Event-Free Survival

An event is defined as treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death. This outcome measure is reported as the percentage of patient that did not have an event at 2 years from registration.

Posted

Number

95% Confidence Interval

percentage of patients

From registration until treatment failure, up to 2 years

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Freedom From Progression

Measured from the time of study entry to progression of disease. Other causes of treatment failure are not include in freedom from progression.

We did not collect the appropriate data to analyze this endpoint. Please see progression free survival endpoint

Posted

from baseline to end of study, approximately 4 years

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Patient Reported Outcomes for Symptoms and Quality of Life

Evaluate patient reported outcomes at baseline and during treatment to determine potential symptom palliation, treatment-related symptoms, and overall health-related quality of life. The Function Assessment of Cancer Therapy for Lymphoma (FACT-Lym) scale has a range of 0(minimum score) to 168 (maximum score). Higher scores indicate a better outcome.

The mean scores for each timepoint are reported below.

Posted

Mean

Standard Deviation

score on a scale

Baseline and AVD Cycle 1, a total of 6 weeks

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

Secondary

Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes

Number of co-morbidities collected for each patient at baseline and at the end of completion of all therapy utilizing the Cumulative Illness Rating Scare (CIRS). For binary outcomes such as CR, logistic regression will be used to assess the relationship with CIRS score; for time-to-event outcomes, the method of Kalan Meier and the log rank test will be used. The minimum score of the CIRS is 0 and the maximum score is 56. High Scores on the CIRS scale indicate that the patient has more severe comorbidities

Only 44 patients were analyzed for this endpoint because there were 4 patients where the CIRS score at baseline was unknown.

Posted

Number

95% Confidence Interval

percentage of participants

approximately 2 years from treatment start

ID	Title	Description
OG000	Treatment (Antibody-drug Conjugate and Combination Chemo)	LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. brentuximab vedotin: Given IV doxorubicin hydrochloride: Given IV vinblastine: Given IV dacarbazine: Given IV quality-of-life assessment: Ancillary studies DNA analysis: Optional correlative studies RNA analysis: Optional correlative studies fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies laboratory biomarker analysis: Optional correlative studies immunohistochemistry staining method: Optional correlative studies polymorphism analysis: Optional correlative studies

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	Treatment (Antibody-drug Conjugate and Combination Chemo)	There is only 1 Arm/Group for this study and each patient receives the same treatment: Lead-In therapy followed by AVD chemotherapy and Consolidation treatment. A secondary endpoint for this study was the safety of the sequential therapy, so toxicity data was collected and reported as a combined dataset for the whole sequential regimen. The data was not split into individual interventions.	5	48	20	48	46	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected48 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Gait disturbance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Hepatic failure	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Hepatobiliary disorders - Other, specify	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Bladder infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Bone infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Soft tissue infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Tooth infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected48 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected48 at risk
Hallucinations	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected48 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Abdominal Pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00014 events11 affected48 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events4 affected48 at risk
Agitation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0006 events4 affected48 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00023 events12 affected48 at risk
Allergic reaction	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events1 affected48 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00014 events9 affected48 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00048 events20 affected48 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00013 events8 affected48 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events4 affected48 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events5 affected48 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00013 events6 affected48 at risk
Ataxia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Atrial flutter	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events6 affected48 at risk
Bladder infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00010 events2 affected48 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00014 events11 affected48 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events7 affected48 at risk
Bronchial infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Cataract	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events6 affected48 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Chronic kidney disease	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events2 affected48 at risk
Concentration impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events6 affected48 at risk
Conjunctivitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00046 events20 affected48 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00024 events18 affected48 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0005 events5 affected48 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events5 affected48 at risk
Delirium	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00030 events18 affected48 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00021 events13 affected48 at risk
Dry eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events5 affected48 at risk
Dysesthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events7 affected48 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events5 affected48 at risk
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 events5 affected48 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00025 events18 affected48 at risk
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events5 affected48 at risk
Ejection fraction decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected48 at risk
Erectile dysfunction	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
eye irritation	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
erythema of R scelerae	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Presbyopia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Altered Depth Perception	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Red eyes, blepharitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG00063 events32 affected48 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG00011 events9 affected48 at risk
Flashing lights	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Floaters	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Gait disturbance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0009 events7 affected48 at risk
Hyperpigmentation of tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
oral bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Flare of diverticulitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Night Sweats	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected48 at risk
hot flashes	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Vein pain (left arm)	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Left medial thigh pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Left Toe Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
leg cramping	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
hand cramping	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
head cold	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
scab like area at port	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events5 affected48 at risk
Genital edema	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events7 affected48 at risk
Hearing impaired	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00032 events9 affected48 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00012 events5 affected48 at risk
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00022 events11 affected48 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 events6 affected48 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events4 affected48 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00023 events9 affected48 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0005 events5 affected48 at risk
Hypersensitivity to chemo	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Fungal Oral Infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events3 affected48 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events6 affected48 at risk
Irritability	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Lipase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 events1 affected48 at risk
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected48 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00029 events11 affected48 at risk
Lymphocyte count increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Malaise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Mucosal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 events4 affected48 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events8 affected48 at risk
Multi-organ failure	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Muscle weakness right-sided	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
toe cramping, bilateral	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected48 at risk
spinal canal stenosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Right Elbow Bursitis with Erythema and Swelling	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Tongue pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Left thigh pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Chest pressure	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
muscle cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events9 affected48 at risk
Myocardial infarction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Nail infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Nail loss	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00045 events24 affected48 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
neoplasm of uncertain behavior of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
tongue tingling	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
lip tingling	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00077 events24 affected48 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected48 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Otitis externa	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG00013 events8 affected48 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Pain of skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Palpitations	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected48 at risk
Pelvic infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events4 affected48 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00070 events29 affected48 at risk
Pharyngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Phlebitis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00016 events7 affected48 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Proteinuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00016 events12 affected48 at risk
stress	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Purpura	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00013 events10 affected48 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
dry nose	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Restrictive cardiomyopathy	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Rhinitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Seizure	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Serum amylase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Sinus bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0008 events7 affected48 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
nail changes	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Folliculitis (upper left extremity)	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Left axillary abscess	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected48 at risk
Seborrheic Keratoses	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Foot Fungal Rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Skin lesions on chest and left shoulder	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
sweet syndrome lesion on right wrist	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
actinic keratoses	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Ptosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Rash on bilateral upper extremities	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
lesions on the R arm and upper back	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Skin induration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 events2 affected48 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Superficial thrombophlebitis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected48 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Upper left molar tooth extraction	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Seborrheic Keratoses Excision	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected48 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Toothache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 events5 affected48 at risk
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events3 affected48 at risk
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 events2 affected48 at risk
Urinary tract pain	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Urine discoloration	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected48 at risk
Vertigo	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events4 affected48 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00010 events9 affected48 at risk
Watering eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected48 at risk
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG0009 events4 affected48 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG00011 events7 affected48 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00047 events14 affected48 at risk

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000079963	Brentuximab Vedotin
D004317	Doxorubicin
D014747	Vinblastine
D003606	Dacarbazine
D019788	Fluorodeoxyglucose F18
D009682	Magnetic Resonance Spectroscopy
C062942	2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
D007150	Immunohistochemistry
D054458	Amplified Fragment Length Polymorphism Analysis

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
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
D014226	Triazenes
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D003847	Deoxyglucose
D003837	Deoxy Sugars
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006652	Histological Techniques
D007158	Immunologic Techniques
D016172	DNA Fingerprinting
D005821	Genetic Techniques
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques

Title	Measurements
	BG0008

Units	Counts
Participants	OG00048

Units	Counts
Participants	OG0000