A Study of Brentuximab Vedotin Combined With Nivolumab fo... | NCT02572167

Name	Class
Bristol-Myers Squibb	INDUSTRY

Label	Type	Description	Intervention Names
Brentuximab Vedotin + Nivolumab	Experimental	Brentuximab vedotin plus nivolumab	Drug: brentuximab vedotin Drug: nivolumab

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles	Brentuximab Vedotin + Nivolumab

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.	Up to 28.9 months
Complete Remission Rate	Number of patients with complete metabolic response (CMR) at end of treatment	Up to 3.42 months

Measure	Description	Time Frame
Objective Response Rate	Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)	Up to 3.42 months
Duration of Complete Response	The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.

Name	Affiliation	Role
Faith Galderisi, DO	Seagen Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010-3000	United States
Stanford Cancer Center

PubMed Identifier	Type	Citation	Retractions
29229594	Result	Herrera AF, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Ansell SM, Moskowitz CH, Fenton K, Ogden CA, Taft D, Zhang Q, Kato K, Campbell M, Advani RH. Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.
33827139

ID	Title	Description
FG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
FG001	Part 2: Staggered Dose Expansion

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 23, 2017	Oct 17, 2022

ID	Title	Description
BG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
BG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
BG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG00155 BG00230 BG00391

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

Number of Participants With Adverse Events (AEs)

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.

The safety analysis set includes all patients who receive any amount of brentuximab vedotin or nivolumab.

Posted

Count of Participants

Participants

Up to 28.9 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Units	Counts
Participants	OG0006 OG00155 OG00230

Title

Denominators

Categories

Any treatment-emergent adverse event (TEAE)

Title	Measurements
	OG0006 OG00155 OG00230

AEs related to brentuximab vedotin only

Primary

Complete Remission Rate

Number of patients with complete metabolic response (CMR) at end of treatment

The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.

Posted

Count of Participants

Participants

Up to 3.42 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Secondary

Objective Response Rate

Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)

The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.

Posted

Count of Participants

Participants

Up to 3.42 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Secondary

Duration of Complete Response

The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.

The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.

Posted

Median

Full Range

Months

Up to 69.3 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Secondary

Duration of Objective Response

The time from start of the first documentation of OR (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first.

The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.

Posted

Median

Full Range

Months

Up to 69.3 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Secondary

Progression-free Survival Post-autologous Stem Cell Transplant

For participants who undergo ASCT, the time from ASCT to the first documentation of PD or to death due to any cause, whichever comes first.

Subset includes all patients who received any amount of brentuximab vedotin or nivolumab and who received a stem cell transplant without intervening salvage after study treatment.

Posted

Median

Full Range

Months

Up to 67.3 months

ID	Title	Description
OG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
OG002	Part 3: Same-Day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Sepsis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Cellulitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Necrotising soft tissue infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Septic shock	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Systemic candida	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0020 affected30 at risk
Colitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Enteritis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Pyrexia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Malaise	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Hypotension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0020 affected30 at risk
Uveitis	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0005 affected6 at risk EG00130 affected55 at risk EG00215 affected30 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00113 affected55 at risk EG00211 affected30 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00114 affected55 at risk EG00210 affected30 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG00112 affected55 at risk EG0026 affected30 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG00111 affected55 at risk EG0025 affected30 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0019 affected55 at risk EG0027 affected30 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0019 affected55 at risk EG0022 affected30 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0016 affected55 at risk EG0024 affected30 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0023 affected30 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0021 affected30 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0023 affected30 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected55 at risk EG0020 affected30 at risk
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Fatigue	General disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00139 affected55 at risk EG00228 affected30 at risk
Pyrexia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00124 affected55 at risk EG00216 affected30 at risk
Chills	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00116 affected55 at risk EG00211 affected30 at risk
Chest discomfort	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0019 affected55 at risk EG0025 affected30 at risk
Pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0029 affected30 at risk
Non-cardiac chest pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0014 affected55 at risk EG0025 affected30 at risk
Oedema peripheral	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0017 affected55 at risk EG0021 affected30 at risk
Asthenia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0016 affected55 at risk EG0021 affected30 at risk
Puncture site pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0023 affected30 at risk
Malaise	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0022 affected30 at risk
Catheter site pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Face oedema	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Catheter site rash	General disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00141 affected55 at risk EG00228 affected30 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0005 affected6 at risk EG00132 affected55 at risk EG00222 affected30 at risk
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00125 affected55 at risk EG00218 affected30 at risk
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG00122 affected55 at risk EG00213 affected30 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0004 affected6 at risk EG00119 affected55 at risk EG00212 affected30 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00114 affected55 at risk EG00210 affected30 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG00112 affected55 at risk EG0023 affected30 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0019 affected55 at risk EG0021 affected30 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG00110 affected55 at risk EG0021 affected30 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0015 affected55 at risk EG0024 affected30 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0014 affected55 at risk EG0021 affected30 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0020 affected30 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0022 affected30 at risk
Flatulence	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00129 affected55 at risk EG00220 affected30 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00124 affected55 at risk EG00216 affected30 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0006 affected6 at risk EG00119 affected55 at risk EG00212 affected30 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0005 affected6 at risk EG00112 affected55 at risk EG0026 affected30 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0017 affected55 at risk EG0027 affected30 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0023 affected30 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00120 affected55 at risk EG00210 affected30 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00115 affected55 at risk EG0028 affected30 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00113 affected55 at risk EG0021 affected30 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG0014 affected55 at risk EG0025 affected30 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0014 affected55 at risk EG0024 affected30 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0017 affected55 at risk EG0021 affected30 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0015 affected55 at risk EG0023 affected30 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0021 affected30 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0023 affected30 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0024 affected30 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0022 affected30 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected55 at risk EG0021 affected30 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Headache	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG00121 affected55 at risk EG00213 affected30 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00119 affected55 at risk EG00210 affected30 at risk
Dizziness	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00113 affected55 at risk EG0024 affected30 at risk
Paraesthesia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0017 affected55 at risk EG0023 affected30 at risk
Dysgeusia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0020 affected30 at risk
Presyncope	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Syncope	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0014 affected55 at risk EG0021 affected30 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0020 affected30 at risk
Somnolence	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00115 affected55 at risk EG0027 affected30 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG0019 affected55 at risk EG0027 affected30 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG00111 affected55 at risk EG0024 affected30 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0004 affected6 at risk EG0017 affected55 at risk EG0026 affected30 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0016 affected55 at risk EG0021 affected30 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0016 affected55 at risk EG0021 affected30 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected55 at risk EG0021 affected30 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00115 affected55 at risk EG00213 affected30 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00110 affected55 at risk EG00210 affected30 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0018 affected55 at risk EG0023 affected30 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0022 affected30 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0025 affected30 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0021 affected30 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0023 affected30 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Anxiety	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00125 affected55 at risk EG00214 affected30 at risk
Insomnia	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG00114 affected55 at risk EG00210 affected30 at risk
Depression	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0017 affected55 at risk EG0024 affected30 at risk
Agitation	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0003 affected6 at risk EG00125 affected55 at risk EG00211 affected30 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0022 affected30 at risk
Hypotension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG00111 affected55 at risk EG0029 affected30 at risk
Flushing	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG00110 affected55 at risk EG0023 affected30 at risk
Hypertension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG00111 affected55 at risk EG0023 affected30 at risk
Hot flush	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0002 affected6 at risk EG0015 affected55 at risk EG0024 affected30 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0020 affected30 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0017 affected55 at risk EG0025 affected30 at risk
Nasopharyngitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0023 affected30 at risk
Folliculitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected55 at risk EG0020 affected30 at risk
Fungal skin infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Oral herpes	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Rash pustular	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Urinary tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Herpes simplex	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Rhinovirus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Transaminases increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Alanine aminotransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Weight decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0022 affected30 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0022 affected30 at risk
Weight increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0021 affected30 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0023 affected30 at risk
International normalised ratio increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Neutrophil count decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Tachycardia	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0019 affected55 at risk EG0024 affected30 at risk
Palpitations	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0022 affected30 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0022 affected30 at risk
Dysuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0023 affected30 at risk
Haematuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0022 affected30 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Polyuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0020 affected30 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Seasonal allergy	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0015 affected55 at risk EG0022 affected30 at risk
Engraftment syndrome	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Hypersensitivity	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Hypothyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0023 affected30 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Thyroiditis	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0021 affected30 at risk
Dry eye	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0014 affected55 at risk EG0021 affected30 at risk
Vision blurred	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected55 at risk EG0022 affected30 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected55 at risk EG0021 affected30 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected55 at risk EG0020 affected30 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected55 at risk EG0024 affected30 at risk
Thrombosis in device	Product Issues	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Swelling face	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected55 at risk EG0020 affected30 at risk
Taste disorder	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected55 at risk EG0022 affected30 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 affected6 at risk EG0016 affected55 at risk EG0021 affected30 at risk

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
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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: Staggered Dose	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles	0	6	0	6	6	6
EG001	Part 2: Staggered Dose Expansion	Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles	8	56	16	55	55	55
EG002	Part 3: Same-day Dose	Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles	3	31	5	30	30	30