A Frontline Therapy Trial in Participants With Advanced C... | NCT01712490

ID	Type	Description
2011-005450-60	EudraCT Number
U1111-1161-4937	Registry Identifier	WHO
12/LO/1950	Registry Identifier	NRES
JapicCTI-142491	Registry Identifier	JapicCTI
REec-2013-0114	Registry Identifier	REec
1025002760	Registry Identifier	TCTIN
C25003CTID	Other Identifier	Israel
2023-506419-16-00	EU Trial (CTIS) Number	EU CTIS

Name	Class
Seagen Inc.	INDUSTRY

Label	Type	Description	Intervention Names
A + AVD	Experimental	A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.	Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine
ABVD	Active Comparator	ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.	Drug: doxorubicin Drug: bleomycin Drug: vinblastine Drug: dacarbazine

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.	A + AVD

Measure	Description	Time Frame
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)	mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.	Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.	Baseline until death (approximately up to 4 years)
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF

Name	Affiliation	Role
Study Director	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
40135712	Derived	Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
37794803	Derived	Crosswell HE, LaCasce AS, Bartlett NL, Straus DJ, Savage KJ, Zinzani PL, Collins GP, Fanale M, Fenton K, Dong C, Miao H, Grigg AP. Brentuximab vedotin with chemotherapy in adolescents and young adults with stage III or IV classical Hodgkin lymphoma in ECHELON-1. Haematologica. 2024 Mar 1;109(3):982-987. doi: 10.3324/haematol.2023.283303. No abstract available.

Label	URL
Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.	View source

ID	Title	Description
FG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 2, 2015	Apr 18, 2018

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

Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)

mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.

The ITT population included all participants randomized to treatment.

Posted

Median

95% Confidence Interval

months

Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts
Participants	OG000664 OG001670

Title

Denominators

Categories

Title	Measurements
	OG000NA(48.2 to NA)Median and confidence interval was not estimable due to low number of participants with events. OG001NA(NA to NA)Median and confidence interval was not estimable due to low number of participants with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (<) 1 favors A+AVD arm.	Log Rank		0.035		Hazard Ratio (HR)	0.770			2-Sided	95	0.603	0.983					Superiority

Secondary

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.

The ITT population included all participants randomized to treatment.

Posted

Median

95% Confidence Interval

months

Baseline until death (approximately up to 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts
Participants

Secondary

Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF

CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.

The ITT population included all participants randomized to treatment.

Posted

Number

percentage of participants

Baseline up to end of randomized regimen (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

The safety population included all enrolled participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts
Participants

Secondary

Number of Participants With Abnormal Clinical Laboratory Values

The safety population included all enrolled participants who received at least 1 dose of any study drug.

Posted

Number

participants

Baseline up to 30 days after last dose of study drug (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts
Participants

Secondary

Event-free Survival (EFS) Per IRF

EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.

The ITT population included all participants randomized to treatment.

Posted

Median

95% Confidence Interval

months

Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Disease-free Survival (DFS) Per IRF

DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.

The ITT included all participants randomized to treatment. The ITT population where participants achieved CR.

Posted

Median

95% Confidence Interval

months

From CR until PD or death (approximately up to 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts

Secondary

Overall Response Rate (ORR) Per IRF

ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

The ITT population included all participants randomized to treatment.

Posted

Number

percentage of participants

Baseline up to end of randomized regimen (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Duration of Response (DOR) Per IRF

DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR.

Posted

Median

95% Confidence Interval

months

From first documented response until PD (approximately 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Duration of Complete Remission (DOCR) Per IRF

DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.

The ITT population included all participants randomized to treatment. The ITT population where participants achieved CR.

Posted

Median

95% Confidence Interval

months

From first documentation of CR until PD (approximately 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy

CR was defined as disappearance of all evidence of disease as determined by an IRF.

The ITT population included all participants randomized to treatment.

Posted

Number

percentage of participants

Baseline up to end of frontline therapy (approximately 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units	Counts
Participants

Secondary

Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy

CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.

The ITT population included all participants randomized to treatment.

Posted

Number

percentage of participants

Baseline up to end of frontline therapy (approximately 4 years)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Secondary

Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2

PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.

The ITT population included all participants randomized to treatment.

Posted

Number

percentage of participants

Cycle 2 Day 25

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
OG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.

Units

Secondary

A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)

The pharmacokinetic (PK) population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The intensive PK (iPK) population was the subset of PK population. The iPK population where data at specified timepoints was available.

Posted

Geometric Mean

Standard Deviation

microgram per milliliter (microgm/mL)

Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Units	Counts
Participants	OG000

Secondary

A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.

Posted

Geometric Mean

Standard Deviation

nanogram per milliliter (ng/mL)

Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Units	Counts
Participants	OG000

Secondary

A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb

Posted

Mean

Standard Deviation

day*microgram per milliliter (day*ug/mL)

Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Units	Counts
Participants	OG000

Secondary

A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE

Posted

Mean

Standard Deviation

day*nanogram per milliliter (day*ng/mL)

Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Units	Counts
Participants	OG000

Secondary

A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin

The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.

The safety population included all enrolled participants who received at least 1 dose of any study drug. The safety population-immunogenicity-evaluable participants where baseline and at least one postbaseline sample was available.

Posted

Number

participants

Baseline up to end of treatment (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT

EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.

The ITT population included all participants randomized to treatment.

Posted

Mean

Standard Deviation

units on scale

Baseline up to end of treatment (approximately 1 year)

ID	Title	Description
OG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG000151 events114 affected662 at risk EG00152 events43 affected659 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00030 events19 affected662 at risk EG0015 events4 affected659 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events7 affected662 at risk EG0013 events3 affected659 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected662 at risk EG0010 events0 affected659 at risk
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00019 events18 affected662 at risk EG00118 events15 affected659 at risk
Lung infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected662 at risk EG0012 events2 affected659 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0013 events3 affected659 at risk
Bronchitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Atypical pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00015 events14 affected662 at risk EG0014 events4 affected659 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00010 events8 affected662 at risk EG0012 events2 affected659 at risk
Bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0014 events4 affected659 at risk
Septic shock	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0006 events4 affected662 at risk EG0010 events0 affected659 at risk
Septic embolus	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Device related infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0008 events7 affected662 at risk EG0012 events2 affected659 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Catheter site infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Lymph gland infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pelvic infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Wound infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0012 events2 affected659 at risk
Tonsillitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Laryngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pharyngeal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Sinusitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0005 events5 affected662 at risk EG0012 events2 affected659 at risk
Bacterial infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Cellulitis orbital	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Gangrene	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0005 events5 affected662 at risk EG0013 events2 affected659 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Anal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Abdominal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Appendicitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Diverticulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Enteritis infectious	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Skin infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected662 at risk EG0011 events1 affected659 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Folliculitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Pneumonia viral	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Viral infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Tooth abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Pericoronitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Periodontitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Staphylococcal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Pyelonephritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Soft tissue infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Aspergillus infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Genital infection female	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Vulvitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Fungal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pneumonia fungal	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Herpes virus infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Herpes zoster	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Infected lymphocele	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Phlebitis infective	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Endocarditis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Encephalitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Flavivirus infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hepatitis B	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0012 events1 affected659 at risk
Influenza	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Moraxella infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG00055 events44 affected662 at risk EG00132 events28 affected659 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0013 events2 affected659 at risk
Pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected662 at risk EG0012 events1 affected659 at risk
Chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Asthenia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Malaise	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Influenza like illness	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Peripheral swelling	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Chills	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Death	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Catheter site haemorrhage	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Catheter site pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Infusion site extravasation	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Complication associated with device	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Oedema peripheral	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Adverse drug reaction	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Device related thrombosis	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00015 events14 affected662 at risk EG0014 events4 affected659 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00011 events11 affected662 at risk EG0013 events3 affected659 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected662 at risk EG0013 events3 affected659 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00012 events11 affected662 at risk EG0017 events6 affected659 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00013 events11 affected662 at risk EG0011 events1 affected659 at risk
Colitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected662 at risk EG0010 events0 affected659 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Gastritis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0014 events3 affected659 at risk
Ileus	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0011 events1 affected659 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0005 events4 affected662 at risk EG0010 events0 affected659 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00011 events11 affected662 at risk EG0019 events9 affected659 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG00113 events12 affected659 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0016 events5 affected659 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0015 events5 affected659 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected662 at risk EG0014 events4 affected659 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0012 events2 affected659 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected662 at risk EG0010 events0 affected659 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events10 affected662 at risk EG0013 events3 affected659 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected662 at risk EG0013 events3 affected659 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events3 affected662 at risk EG0011 events1 affected659 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0005 events5 affected662 at risk EG0013 events2 affected659 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected662 at risk EG0011 events1 affected659 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Embolism	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0014 events4 affected659 at risk
Venous thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Brachiocephalic vein occlusion	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Phlebitis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Syncope	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected662 at risk EG0012 events2 affected659 at risk
Lethargy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Somnolence	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0013 events3 affected659 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0010 events0 affected659 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Polyneuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Lacunar infarction	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Facial paralysis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events1 affected662 at risk EG0010 events0 affected659 at risk
Hemiparesis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events1 affected662 at risk EG0010 events0 affected659 at risk
Neuralgia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Spinal cord ischaemia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0011 events1 affected659 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Angina pectoris	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected662 at risk EG0011 events1 affected659 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0012 events2 affected659 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pericarditis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Neutrophil count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0011 events1 affected659 at risk
Pseudomonas test positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Staphylococcus test positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Blood glucose increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Amylase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Lipase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected662 at risk EG0010 events0 affected659 at risk
Blood bilirubin increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Body temperature increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0011 events1 affected659 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected662 at risk EG0010 events0 affected659 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Anxiety	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0012 events1 affected659 at risk
Agitation	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Delirium	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected662 at risk EG0010 events0 affected659 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected662 at risk EG0010 events0 affected659 at risk
Anuria	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events1 affected662 at risk EG0010 events0 affected659 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0011 events1 affected659 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Branchial cyst	Congenital, familial and genetic disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected662 at risk EG0010 events0 affected659 at risk
Cushing's syndrome	Endocrine disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk
Vision blurred	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected662 at risk EG0011 events1 affected659 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001,169 events374 affected662 at risk EG001813 events291 affected659 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG000237 events136 affected662 at risk EG00197 events65 affected659 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG000124 events42 affected662 at risk EG001118 events37 affected659 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000673 events346 affected662 at risk EG001735 events369 affected659 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000361 events273 affected662 at risk EG001336 events239 affected659 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000342 events212 affected662 at risk EG001284 events183 affected659 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000231 events176 affected662 at risk EG001155 events121 affected659 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000182 events138 affected662 at risk EG001135 events104 affected659 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000185 events135 affected662 at risk EG00179 events65 affected659 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG000100 events84 affected662 at risk EG00193 events75 affected659 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00074 events64 affected662 at risk EG00137 events34 affected659 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00036 events33 affected662 at risk EG00149 events47 affected659 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG000272 events209 affected662 at risk EG001293 events211 affected659 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG000224 events149 affected662 at risk EG001191 events128 affected659 at risk
Asthenia	General disorders	MedDRA (19.0)	Systematic Assessment	EG00097 events65 affected662 at risk EG00166 events42 affected659 at risk
Chills	General disorders	MedDRA (19.0)	Systematic Assessment	EG00052 events37 affected662 at risk EG00151 events46 affected659 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG00040 events37 affected662 at risk EG00153 events45 affected659 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00076 events68 affected662 at risk EG00175 events69 affected659 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00039 events28 affected662 at risk EG00140 events35 affected659 at risk
Weight decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG000168 events148 affected662 at risk EG00146 events40 affected659 at risk
Neutrophil count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG000285 events86 affected662 at risk EG001191 events78 affected659 at risk
Alanine aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00092 events68 affected662 at risk EG00128 events26 affected659 at risk
White blood cell count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00081 events46 affected662 at risk EG00159 events34 affected659 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00058 events47 affected662 at risk EG00121 events19 affected659 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00041 events34 affected662 at risk EG00113 events10 affected659 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG000156 events118 affected662 at risk EG001106 events76 affected659 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00050 events45 affected662 at risk EG00135 events24 affected659 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00044 events34 affected662 at risk EG00118 events14 affected659 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000200 events125 affected662 at risk EG00187 events66 affected659 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000113 events89 affected662 at risk EG00198 events77 affected659 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000127 events80 affected662 at risk EG00187 events70 affected659 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000108 events79 affected662 at risk EG00193 events67 affected659 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00096 events82 affected662 at risk EG00159 events49 affected659 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00048 events40 affected662 at risk EG00134 events29 affected659 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00041 events36 affected662 at risk EG00118 events17 affected659 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG000298 events189 affected662 at risk EG001149 events111 affected659 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG000261 events174 affected662 at risk EG001103 events85 affected659 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG000124 events93 affected662 at risk EG001117 events92 affected659 at risk
Paraesthesia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG000120 events84 affected662 at risk EG00189 events73 affected659 at risk
Dizziness	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG00074 events64 affected662 at risk EG00165 events57 affected659 at risk
Dysgeusia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG00052 events48 affected662 at risk EG00168 events48 affected659 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG00050 events40 affected662 at risk EG0019 events8 affected659 at risk
Insomnia	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG000134 events126 affected662 at risk EG00189 events82 affected659 at risk
Anxiety	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG00053 events50 affected662 at risk EG00152 events49 affected659 at risk
Depression	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG00036 events35 affected662 at risk EG00127 events25 affected659 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG000108 events97 affected662 at risk EG001139 events122 affected659 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00097 events79 affected662 at risk EG001136 events121 affected659 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00082 events72 affected662 at risk EG00165 events55 affected659 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00041 events40 affected662 at risk EG00131 events28 affected659 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG000194 events173 affected662 at risk EG001165 events146 affected659 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00060 events43 affected662 at risk EG00133 events28 affected659 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D006689	Hodgkin Disease
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
D001761	Bleomycin
D014747	Vinblastine
D003606	Dacarbazine

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
D006020	Glycopeptides
D006001	Glycoconjugates
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

ID	Title	Description
BG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
BG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	A+AVD	Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.	9	662	284	662	644	662
EG001	ABVD	Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.	13	659	178	659	632	659