Nivolumab Combined With Ipilimumab Followed by Nivolumab... | NCT02599402

ID	Type	Description	Link
2015-001274-17	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination therapy: Nivolumab + Ipilimumab	Experimental	Nivolumab + Ipilimumab specified dose on specified days	Drug: Nivolumab Drug: Ipilimumab
Monotherapy: Nivolumab	Experimental	Nivolumab specified dose on specified days	Drug: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug		Combination therapy: Nivolumab + Ipilimumab Monotherapy: Nivolumab
Ipilimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events	Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events	Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)

Eligibility Module

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Garran	Australian Capital Territory	2605	Australia
Local Institution

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37307514	Derived	Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab + Ipilimumab Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240 mg) IV Q2W up to 21 months

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 31, 2018	Apr 23, 2021

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.0± 13.55

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000217
Male	BG000316

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005
Not Hispanic or Latino	BG000515

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0002

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

Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events

Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months
OG001	Nivolumab + Ipilimumab ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup
OG002	Nivolumab + Ipilimumab ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup
OG003	Nivolumab + Ipilimumab Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Brain Metastasis subgroup
OG004	Nivolumab + Ipilimumab Mucosal	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Mucosal
OG005	Nivolumab + Ipilimumab Ocular/Uveal	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Ocular/Uveal
OG006	Nivolumab + Ipilimumab Cutaneous	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Cutaneous
OG007	Nivolumab + Ipilimumab Acral	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Acral
OG008	Nivolumab + Ipilimumab Other	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Other

Units	Counts
Participants	OG000533 OG001477 OG00255 OG003

Title

Denominators

Categories

Pulmonary: Grade 3-4

Title	Measurements
	OG0007 OG0017 OG0020 OG003

Secondary

Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events

Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Median Time to Onset (Grades 3-4) of Select Adverse Events

Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category

Posted

Median

Full Range

Days

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Median Time to Resolution (Grades 3-4) of Select Adverse Events

Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category

Posted

Median

Full Range

Days

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Time to Resolution of an Adverse Event (AE)

Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one select adverse event from the category

Posted

Median

Full Range

Days

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis

Secondary

Overall Survival (OS)

Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Median

95% Confidence Interval

Months

Up to approximately 37 months

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Incidence of Participants With Adverse Events

The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Incidence of Participants With Select Adverse Events

The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Incidence of Participants With Laboratory Abnormalities - Liver

Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment measurement of the corresponding laboratory parameter

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis

Secondary

Incidence of Participants With Laboratory Abnormalities - Thyroid

Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups with at least one on-treatment TSH measurement

Posted

Count of Participants

Participants

From first dose to 30 days after last dose (up to approximately 37 months)

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Objective Response Rate (ORR)

Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 37 months

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Secondary

Progression Free Survival (PFS)

Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.

All treated participants and ECOG, Brain Metastasis, and Disease Subtype subgroups

Posted

Median

95% Confidence Interval

Months

Up to approximately 37 months

ID	Title	Description
OG000	Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG001	ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG002	ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W
OG003	Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nivolumab + Ipilimumab Total	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months	199	533	356	533	503	533
EG001	Nivolumab + Ipilimumab ECOG PS0-1	Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup	169	477	324	477	453	477
EG002	Nivolumab + Ipilimumab ECOG PS2	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup	29	55	31	55	49	55
EG003	Nivolumab + Ipilimumab Brain Metastasis	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Brain Metastasis subgroup	13	42	31	42	37	42
EG004	Nivolumab + Ipilimumab Mucosal	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Mucosal	20	32	26	32	28	32
EG005	Nivolumab + Ipilimumab Ocular/Uveal	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Ocular/Uveal	41	64	40	64	61	64
EG006	Nivolumab + Ipilimumab Cutaneous	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Cutaneous	107	365	238	365	347	365
EG007	Nivolumab + Ipilimumab Acral	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Acral	6	10	9	10	10	10
EG008	Nivolumab + Ipilimumab Other	Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Other	25	62	43	62	57	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG0030 affected42 at risk EG0040 affected32 at risk EG0050 affected64 at risk EG0061 affected365 at risk EG0070 affected10 at risk EG0080 affected62 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Autoimmune pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0011 affected477 at risk EG0021 affected55 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0016 affected477 at risk EG0020 affected55 at risk EG003
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0008 affected533 at risk EG0018 affected477 at risk EG0020 affected55 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG00023 affected533 at risk EG00123 affected477 at risk EG0020 affected55 at risk EG003
Hypopituitarism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Immune-mediated hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Lymphocytic hypophysitis	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0016 affected477 at risk EG0020 affected55 at risk EG003
Primary adrenal insufficiency	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Thyroiditis acute	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Autoimmune uveitis	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Diplopia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Photopsia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Retinal detachment	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected533 at risk EG0015 affected477 at risk EG0020 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00012 affected533 at risk EG00111 affected477 at risk EG0021 affected55 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00043 affected533 at risk EG00141 affected477 at risk EG0022 affected55 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00036 affected533 at risk EG00134 affected477 at risk EG0022 affected55 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected533 at risk EG0019 affected477 at risk EG0020 affected55 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected533 at risk EG0015 affected477 at risk EG0020 affected55 at risk EG003
Pancreatic failure	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
General physical health deterioration	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hyperthermia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Polyserositis	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected533 at risk EG00114 affected477 at risk EG0020 affected55 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG00015 affected533 at risk EG00114 affected477 at risk EG0021 affected55 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Hepatocellular injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0008 affected533 at risk EG0017 affected477 at risk EG0021 affected55 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG00015 affected533 at risk EG00115 affected477 at risk EG0020 affected55 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Abscess limb	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Alveolar osteitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Device related infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Encephalitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Endocarditis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Erysipelas	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pneumococcal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pyoderma	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0015 affected477 at risk EG0021 affected55 at risk EG003
Septic arthritis streptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Urosepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Wound infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0016 affected477 at risk EG0020 affected55 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
C-reactive protein increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
General physical condition abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 affected533 at risk EG0014 affected477 at risk EG0021 affected55 at risk EG003
Liver function test increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Transaminases increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
White blood cells urine positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0016 affected477 at risk EG0020 affected55 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0011 affected477 at risk EG0021 affected55 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG00071 affected533 at risk EG00157 affected477 at risk EG00214 affected55 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Ataxia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Autoimmune neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Autonomic neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Cubital tunnel syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0008 affected533 at risk EG0017 affected477 at risk EG0021 affected55 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Petit mal epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected533 at risk EG00110 affected477 at risk EG0020 affected55 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Immune-mediated renal disorder	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0011 affected477 at risk EG0021 affected55 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0015 affected477 at risk EG0021 affected55 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected533 at risk EG0016 affected477 at risk EG0020 affected55 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected533 at risk EG0019 affected477 at risk EG0020 affected55 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected533 at risk EG0013 affected477 at risk EG0020 affected55 at risk EG003
Pulmonary haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected533 at risk EG0014 affected477 at risk EG0020 affected55 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected533 at risk EG0012 affected477 at risk EG0020 affected55 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Shock	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Vasculitis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Vein collapse	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0011 affected477 at risk EG0020 affected55 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected533 at risk EG0010 affected477 at risk EG0021 affected55 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00057 affected533 at risk EG00150 affected477 at risk EG0027 affected55 at risk EG0032 affected42 at risk EG0042 affected32 at risk EG0056 affected64 at risk EG00635 affected365 at risk EG0073 affected10 at risk EG00811 affected62 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG00098 affected533 at risk EG00196 affected477 at risk EG0022 affected55 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG00030 affected533 at risk EG00127 affected477 at risk EG0023 affected55 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG000110 affected533 at risk EG001104 affected477 at risk EG0026 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00073 affected533 at risk EG00171 affected477 at risk EG0022 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00036 affected533 at risk EG00133 affected477 at risk EG0023 affected55 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00083 affected533 at risk EG00177 affected477 at risk EG0026 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000224 affected533 at risk EG001209 affected477 at risk EG00215 affected55 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00051 affected533 at risk EG00150 affected477 at risk EG0021 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000156 affected533 at risk EG001144 affected477 at risk EG00211 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00082 affected533 at risk EG00175 affected477 at risk EG0027 affected55 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG00096 affected533 at risk EG00182 affected477 at risk EG00214 affected55 at risk EG003
Chills	General disorders	MedDRA 23.0	Systematic Assessment	EG00027 affected533 at risk EG00126 affected477 at risk EG0021 affected55 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG000178 affected533 at risk EG001173 affected477 at risk EG0025 affected55 at risk EG003
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG00041 affected533 at risk EG00141 affected477 at risk EG0020 affected55 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00034 affected533 at risk EG00131 affected477 at risk EG0023 affected55 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG000130 affected533 at risk EG001111 affected477 at risk EG00219 affected55 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00050 affected533 at risk EG00149 affected477 at risk EG0021 affected55 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG000101 affected533 at risk EG00191 affected477 at risk EG00210 affected55 at risk EG003
Amylase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00039 affected533 at risk EG00135 affected477 at risk EG0024 affected55 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00085 affected533 at risk EG00177 affected477 at risk EG0028 affected55 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00028 affected533 at risk EG00126 affected477 at risk EG0022 affected55 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00028 affected533 at risk EG00126 affected477 at risk EG0022 affected55 at risk EG003
Lipase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00075 affected533 at risk EG00168 affected477 at risk EG0027 affected55 at risk EG003
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00053 affected533 at risk EG00149 affected477 at risk EG0024 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG000115 affected533 at risk EG001108 affected477 at risk EG0027 affected55 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00040 affected533 at risk EG00136 affected477 at risk EG0024 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00075 affected533 at risk EG00173 affected477 at risk EG0022 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00049 affected533 at risk EG00145 affected477 at risk EG0024 affected55 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00029 affected533 at risk EG00128 affected477 at risk EG0021 affected55 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00040 affected533 at risk EG00136 affected477 at risk EG0024 affected55 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00036 affected533 at risk EG00133 affected477 at risk EG0023 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG000117 affected533 at risk EG001110 affected477 at risk EG0027 affected55 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00058 affected533 at risk EG00152 affected477 at risk EG0026 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG000108 affected533 at risk EG00198 affected477 at risk EG00210 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00059 affected533 at risk EG00156 affected477 at risk EG0023 affected55 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG000146 affected533 at risk EG001135 affected477 at risk EG00211 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00082 affected533 at risk EG00176 affected477 at risk EG0026 affected55 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00033 affected533 at risk EG00131 affected477 at risk EG0022 affected55 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00064 affected533 at risk EG00158 affected477 at risk EG0026 affected55 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00033 affected533 at risk EG00131 affected477 at risk EG0022 affected55 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00067 affected533 at risk EG00158 affected477 at risk EG0029 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00027 affected533 at risk EG00127 affected477 at risk EG0020 affected55 at risk EG003

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins