Dose-escalation Study of Combination BMS-936558 (MDX-1106... | NCT01024231

ID	Type	Description	Link
(MDX1106-04)	Other Identifier	Medarex

Name	Class
Medarex	INDUSTRY
Ono Pharma USA Inc	INDUSTRY

Label	Type	Description	Intervention Names
Cohort 1: BMS-936558 (0.3 mg/kg)+Ipilimumab (3 mg/kg)	Experimental	BMS-936558 (MDX1106-04) 0.3 mg/kg solution, 60 minutes intravenous infusion every 3 (q3) weeks for 21 weeks in induction and every 12 (q12) weeks for 84 weeks in maintenance Ipilimumab (BMS-734016) 3 mg/kg solution, 90 minutes intravenous infusion q3 weeks for 9 weeks in induction and q12 weeks for 84 weeks in maintenance	Drug: BMS-936558 (MDX1106-04) Drug: Ipilimumab
Cohort 2: BMS-936558 (1 mg/kg)+Ipilimumab (3 mg/kg)	Experimental	Ipilimumab (BMS-734016) 3 mg/kg solution, 90 minutes intravenous infusion, q3 weeks for 9 weeks in induction and q12 weeks for 84 weeks in maintenance BMS-936558 (MDX1106-04) 1 mg/kg solution, 60 minutes intravenous infusion, q3 weeks for 21 weeks in induction and q12 weeks for 84 weeks in maintenance	Drug: BMS-936558 (MDX1106-04) Drug: Ipilimumab
Cohort 3: BMS-936558 (3 mg/kg)+Ipilimumab (3 mg/kg)	Experimental	Ipilimumab (BMS-734016) 3 mg/kg solution, 90 minutes intravenous infusion, q3 weeks for 9 weeks in induction and q12 weeks for 84 weeks in maintenance BMS-936558 (MDX1106-04) 3 mg/kg solution, 60 minutes intravenous infusion, q3 weeks for 21 weeks in induction and q12 weeks for 84 weeks in maintenance	Drug: BMS-936558 (MDX1106-04) Drug: Ipilimumab
Cohort 4: BMS-936558 (10 mg/kg)+Ipilimumab (3 mg/kg)	Experimental	BMS-936558 (MDX1106-04) 10 mg/kg solution, 60 minutes intravenous infusion, q3 weeks for 21 weeks in induction and q12 weeks for 84 weeks in maintenance Ipilimumab (BMS-734016) 3 mg/kg solution, 90 minutes intravenous infusion, q3 weeks for 9 weeks in induction and q12 weeks for 84 weeks in maintenance

Name	Type	Description	Arm Group Labels	Other Names
BMS-936558 (MDX1106-04)	Drug		Cohort 1: BMS-936558 (0.3 mg/kg)+Ipilimumab (3 mg/kg) Cohort 2: BMS-936558 (1 mg/kg)+Ipilimumab (3 mg/kg) Cohort 3: BMS-936558 (3 mg/kg)+Ipilimumab (3 mg/kg) Cohort 4: BMS-936558 (10 mg/kg)+Ipilimumab (3 mg/kg)

Measure	Description	Time Frame
Number of Participants With an Adverse Event (AE)	incidence of all cause and treatment related adverse events	Up to 3 years
Number of Participants With a Serious Adverse Event (AE)	incidence of all cause and treatment related serious adverse events	Up to 3 years
Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation	incidence of all cause and treatment related adverse events which lead to discontinuation	Up to 3 years
Number of Deaths	incidence of all cause and treatment related deaths	Up to 3 years
Number of Participants With Select AEs	incidence of all cause and treatment related Adverse events in certain organ systems	Up to 3 years
Laboratory Abnormalities: Specific Liver Tests	Number of Participants with On-Treatment Laboratory Abnormalities in Specific Liver Tests Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)	Up to 3 years
Laboratory Abnormalities: Specific Thyroid Tests	Number of Participants with On-Treatment Laboratory Abnormalities in Specific Thyroid Tests Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)	Up to 3 years

Measure	Description	Time Frame
Objective Response Rate	the total number of participants whose best overall response (BOR) is either irCR or irPR divided by the total number of response-evaluable participants.	Up to 3 years
Time to Response

Eligibility Module

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histologic diagnosis of malignant melanoma (MEL)
Measurable unresectable Stage III or IV MEL
ECOG performance status score of 0 or 1
Life expectancy ≥4 months
For those enrolled in amendment 5 and later, tumor tissue (archival or recent acquisition) must be available
For Cohorts 1-5, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma not including any post-incisional adjuvant therapy. Subjects may be treatment naïve. All metastatic melanoma regardless of primary site of disease will be allowed
For Cohorts 6-7, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma; this does not include any post-incisional adjuvant therapy. Specifically, subjects must have received ≥3 doses of Ipilimumab therapy and the last dose having been administered within 4-12 weeks of initiation of study treatment

Exclusion Criteria:

History of severe hypersensitivity reactions to other mAbs
Prior malignancy active within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the investigator present a low risk for recurrence
Active autoimmune disease or a history of known or suspected autoimmune disease
History of recently active diverticulitis or symptomatic peptic ulcer disease and history of adrenal insufficiency
Regular narcotic analgesia
Active, untreated central nervous system metastasis
For subjects enrolled in Cohorts 1-5, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
For subjects enrolled in Cohorts 6-7, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CD137 antibodies
Any non-oncology vaccine therapy used for prevention of infectious disease
Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs
Positive tests for human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B, hepatitis C
Subjects weighing ≥125 kg are excluded from Cohort 5
Subjects in Cohorts 6 and 7 must have received Ipilimumab monotherapy immediately prior to study entry, but must not have received that Ipilimumab as part of a clinical trial
Subjects with ocular melanoma are excluded from Cohort 8

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

Facility	Status	City	State	ZIP	Country	Contacts
Yale University School Of Medicine		New Haven	Connecticut	06520	United States
Medstar Georgetown-Lombardi Comprehensive Cancer Center

PubMed Identifier	Type	Citation	Retractions
39504507	Derived	Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
29040030

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
FG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Aug 20, 2014	Aug 28, 2020

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 an Adverse Event (AE)

incidence of all cause and treatment related adverse events

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3
OG005	Cohort 6	1mg/kg of BMS-936558 (MDX-1106)
OG006	Cohorot 7	3 mg/kg of BMS-936558 (MDX-1106)
OG007	Only BMS	combined total of participants who receive BMS only
OG008	Cohort 8	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
OG009	Any BMS/Ipi	All participants who received both BMS and Ipi
OG010	Total	All Participants who received treatment in any cohort combined

Units	Counts
Participants	OG00014 OG00117 OG00216 OG003

Title

Denominators

Categories

All Cause

Title	Measurements
	OG00014 OG00117 OG00216 OG003

Primary

Number of Participants With a Serious Adverse Event (AE)

incidence of all cause and treatment related serious adverse events

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Primary

Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation

incidence of all cause and treatment related adverse events which lead to discontinuation

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Primary

Number of Deaths

incidence of all cause and treatment related deaths

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3
OG005

Primary

Number of Participants With Select AEs

incidence of all cause and treatment related Adverse events in certain organ systems

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Primary

Laboratory Abnormalities: Specific Liver Tests

Number of Participants with On-Treatment Laboratory Abnormalities in Specific Liver Tests Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Primary

Laboratory Abnormalities: Specific Thyroid Tests

Number of Participants with On-Treatment Laboratory Abnormalities in Specific Thyroid Tests Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)

All Treated Participants

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Secondary

Objective Response Rate

the total number of participants whose best overall response (BOR) is either irCR or irPR divided by the total number of response-evaluable participants.

All Treated Participants

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Secondary

Time to Response

the time from the first dose of study drug until the first documentation of irCR or irPR, as related to current database lock date or most current tumor measurement

All Treated Participants

Posted

Median

Full Range

Weeks

Up to 3 Years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Secondary

Duration of Response

the time from the first documented response (irCR or irPR) until progression or death, whichever occurs first. For participants who did not progress or die, duration of response will be censored on the date of the last tumor assessment.

All Treated Participants with a response

Posted

Median

95% Confidence Interval

Weeks

from the first documented response (irCR or irPR) until progression or death

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo

Secondary

Progression Free Survival

the time from the first dose to the first observation of disease progression or death due to any cause. If a participant has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. Participants who did not have any on-study tumor assessments and did not die will be censored on the date of the first dose of study medication.

All Treated Participants

Posted

Median

95% Confidence Interval

Weeks

156 weeks

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004

Secondary

Number of Participants With an Anti-Drug Antibody (ADA) Response for Nivolumab (Nivo) and Ipilimumab (Ipi)

Serum samples will be collected to evaluate the development of antibodies to BMS-936558 and to ipilimumab.

All Treated Participants with baseline and at least one post baseline assessment

Posted

Count of Participants

Participants

Up to 3 years

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo

Secondary

Peak and Trough Concentrations

The peak and trough concentrations of BMS-936558 (MDX-1106) and ipilimumab in participants with quantifiable data

All Treated Participants with quantifiable data

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Up to 64 Weeks

ID	Title	Description
OG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
OG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
OG004	Any BMS and Ipi Combo	All participants who received treatment in Cohorts 1 through 3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0013 affected17 at risk EG0020 affected16 at risk EG0030 affected6 at risk EG0040 affected17 at risk EG0051 affected16 at risk EG0062 affected41 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0022 affected16 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Asthenia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Disease Progression	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0013 affected17 at risk EG0022 affected16 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0013 affected17 at risk EG0022 affected16 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Superinfection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Urinary Tract Infections	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Autoimmune Disorder	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Convulsions	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Tubulointerstitial Nephritis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Appendix Disorders	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Amylase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Lipase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Uveitis	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Vision Blurred	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Central Nervous System Necrosis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Adrenal Insufficiency	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Chorioretinitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Confusional State	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Diverticular Perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Blood Urea Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Troponin 1 Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Cerebral Ischemia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Viral Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0023 affected16 at risk EG003
Death	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Sudden Death	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Anemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Device Related Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Mental Status Changes	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Chest Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Failure to Thrive	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Bone Lesion	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Cognitive Disorders	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hospitalizations	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Gastrointestinal Pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Aphasia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Urinary Tract Infection	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Multiorgan Failure	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Edema Peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Enterococcal Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dry Eye	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Embolism	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hemorrhage	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hemolysis	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Metastasis to Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Central Nervous System Hemorrhage	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Acute Cholecystitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Troponin T Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pneumonitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected14 at risk EG0015 affected17 at risk EG0024 affected16 at risk EG0033 affected6 at risk EG0044 affected17 at risk EG0056 affected16 at risk EG00620 affected41 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG0016 affected17 at risk EG0028 affected16 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected14 at risk EG0014 affected17 at risk EG0024 affected16 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0013 affected17 at risk EG0023 affected16 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0013 affected17 at risk EG0023 affected16 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0022 affected16 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0022 affected16 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hemorrhoids	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Gingival Pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Tongue Ulceration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Anal Pruritis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Anorectal Discomfort	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Aphthous Stomatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Gingival Bleeding	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lip Dry	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Tongue Discoloration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Tongue Edema	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected14 at risk EG00111 affected17 at risk EG00211 affected16 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected14 at risk EG00111 affected17 at risk EG00212 affected16 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0014 affected17 at risk EG0023 affected16 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Acute Febrile Neutrophilic Dermatosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Butterfly Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hair Color Changes	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lichenoid Keratosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected14 at risk EG00111 affected17 at risk EG0027 affected16 at risk EG003
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG0017 affected17 at risk EG0023 affected16 at risk EG003
Chills	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0015 affected17 at risk EG0021 affected16 at risk EG003
Edema Peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected17 at risk EG0021 affected16 at risk EG003
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Asthenia	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Edema	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Chest Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Chest Discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Influenza Like Illness	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Mucosal Inflammation	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Xerosis	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Axillary Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Local Swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Thirst	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Catheter Site Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Early Satiety	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Facial Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Feeling Jittery	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hernia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Injection Site Reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Sensation of Foreign Body	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG0016 affected17 at risk EG0027 affected16 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0012 affected17 at risk EG0023 affected16 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Respiratory Tract Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Throat Tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Sleep Apnea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Arthalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG0013 affected17 at risk EG0023 affected16 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0011 affected17 at risk EG0024 affected16 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0010 affected17 at risk EG0023 affected16 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0021 affected16 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lipase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0014 affected17 at risk EG0023 affected16 at risk EG003
Amylase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0014 affected17 at risk EG0022 affected16 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Weight Decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0023 affected16 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected17 at risk EG0020 affected16 at risk EG003
Hemoglobin Decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Weight Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Gamma-Glutamyltransferase Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Blood Thyroid Stimulating Hormone Decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Electrocardiogram QT Prolonged	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
International Normalized Ratio Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Albumin Decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Blood Phosphorus Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Potassium Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Testosterone Decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Blood Uric Acid Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Breath Sounds Abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Chest X-Ray Abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Fungal Test Positive	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Thyroid Function Test Abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Transaminases Increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0018 affected17 at risk EG0024 affected16 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0013 affected17 at risk EG0021 affected16 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected14 at risk EG0013 affected17 at risk EG0020 affected16 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected17 at risk EG0022 affected16 at risk EG003
Ataxia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Tremor	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0022 affected16 at risk EG003
Ageusia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Amnesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lethargy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Presyncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Cognitive Disorder	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dizziness Postural	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Memory Impairment	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Migraine with Aura	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Mononeuropathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Narcolepsy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Sciatica	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Sinus Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Somnolence	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0014 affected17 at risk EG0023 affected16 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hyperphosphatemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Increased Appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Upper Respiratory Tract Infections	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0021 affected16 at risk EG003
Urinary Tract Infections	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected17 at risk EG0020 affected16 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Candida Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Oral Herpes	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Herpes Zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Cellulitis Orbital	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Clostridium Difficile Colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Escherichia Bacteremia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Tooth Abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Viral Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Wound Infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Vision Blurred	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dry Eye	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Uveitis	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Ocular Hyperemia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Eye Pain	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Eye Pruritus	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Eye Swelling	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Eyelid Margin Crusting	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hypermetropia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Ophthalmoplegia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Photophobia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Vitreous Floaters	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Adrenal Insufficiency	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected17 at risk EG0023 affected16 at risk EG003
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Flushing	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hemorrhage	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hot Flush	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected17 at risk EG0021 affected16 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Confusional State	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected17 at risk EG0020 affected16 at risk EG003
Mood Altered	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Mental Status Changes	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Anemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Iron Deficiency Anemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Lymph Node Pain	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Radiation Necrosis	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Radiation Skin Injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Micturition Urgency	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Urethral Discharge	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Urinary Tract Disorder	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Palpitations	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Pericardial Effusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hearing Impaired	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Ear Pruritus	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Tumor Hemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Breast Cyst	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Gynecomastia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Polymenorrhea	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Vaginal Hemorrhage	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected17 at risk EG0020 affected16 at risk EG003
Vulvovaginal Dryness	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0021 affected16 at risk EG003
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected17 at risk EG0020 affected16 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

ID	Title	Description
BG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
BG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
BG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab
BG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab
BG004	Cohort 6	1mg/kg of BMS-936558 (MDX-1106)
BG005	Cohorot 7	3 mg/kg of BMS-936558 (MDX-1106)
BG006	Cohort 8	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
BG007	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	8	14	10	14	14	14
EG001	Cohort 2	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	4	17	15	17	17	17
EG002	Cohort 2a	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	2	16	10	16	16	16
EG003	Cohort 3	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	0	6	5	6	6	6
EG004	Cohort 6	1mg/kg of BMS-936558 (MDX-1106)	7	17	9	17	17	17
EG005	Cohorot 7	3 mg/kg of BMS-936558 (MDX-1106)	8	16	10	16	15	16
EG006	Cohort 8	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	8	41	26	41	41	41