An Investigational Immuno-therapy Study to Determine the... | NCT02253992

ID	Type	Description	Link
2014-002241-22	EudraCT Number

Label	Type	Description	Intervention Names
Dose Escalation and Cohort expansion: Urelumab + Nivolumab	Experimental	Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles	Biological: Urelumab Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Urelumab	Biological		Dose Escalation and Cohort expansion: Urelumab + Nivolumab	BMS-663513

Measure	Description	Time Frame
The Incidence of Adverse Events.		From day 1 until 100 days after participant last dose of study drug.
The Incidence of Seriuos Adverse Events.		From day 1 until 100 days after participant last dose of the study drug.
The Incidence of Death.		From day 1 until 100 days after participant last dose of study drug.

Measure	Description	Time Frame
Best Overall Response (BOR)	The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

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

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School Of Medicine		Palo Alto	California	94304	United States
H. Lee Moffitt Cancer Center

PubMed Identifier	Type	Citation	Retractions
38458639	Derived	Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	TRT A	URE3 Q4WK+NIV3 Q2WK
FG001	TRT B	URE8 Q4WK+NIV3 Q2WK
FG002

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 18, 2016	May 19, 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

The Incidence of Adverse Events.

All treated participants

Posted

Number

Number of participants

From day 1 until 100 days after participant last dose of study drug.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG0006 OG0014 OG002150

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0014 OG002150

Primary

The Incidence of Seriuos Adverse Events.

All treated participants

Posted

Number

Number of participants

From day 1 until 100 days after participant last dose of the study drug.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Primary

The Incidence of Death.

All Treated participants

Posted

Number

Number of participants

From day 1 until 100 days after participant last dose of study drug.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Best Overall Response (BOR)

The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.

All treated Participants

Posted

Number

Number of participants

Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

ID	Title	Description
OG000	TRT D - NSCLC pd1/Pd-l1 Experienced	URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced
OG001	TRT D - NSCLC pd1/Pd-l1 Naive	URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.
OG002	TRT D - Melanoma pd1/Pd-l1 Experienced	URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced
OG003	TRT A - Melanoma pd1/Pd-l1 Naive	URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive

Secondary

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.

All treated Participants

Posted

Number

95% Confidence Interval

Percentage of participants

Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

ID	Title	Description
OG000	TRT D - NSCLC pd1/Pd-l1 Experienced	URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced
OG001	TRT D - NSCLC pd1/Pd-l1 Naive	URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.
OG002	TRT D - Melanoma pd1/Pd-l1 Experienced	URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced
OG003	TRT A - Melanoma pd1/Pd-l1 Naive	URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
OG004

Secondary

Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab

All treated participants

Posted

Number

Number of participants

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	Urelumab ADA	Urelumab Anti drug antibody
OG001	Nivolumab ADA	Nivolumab anti drug antibody

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR)

DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first.

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants

Secondary

Progression-free Survival Rate (PFSR)

PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time.

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Maximum Observed Serum Concentration (Cmax)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Time of Maximum Observed Serum Concentration (Tmax)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Trough Observed Plasma Concentration(Ctrough)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

End of Infusion Concentration (Ceoinf)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)

Data was not collected due to discontinuation of the study/Due to study termination.

Posted

Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

ID	Title	Description
OG000	TRT A	URE3 Q4WK+NIV3 Q2WK
OG001	TRT B	URE8 Q4WK+NIV3 Q2WK
OG002	TRT D	URE8 Q4WK+NIV240mg Q2WK

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Atrioventricular block	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Diabetes insipidus	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypogonadism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypophysitis	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypothyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Colitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Enteritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Ileus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
General physical health deterioration	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Hyperthermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypothermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Pelvic mass	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0025 affected150 at risk
Sudden death	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Contrast media reaction	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Device related infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Erysipelas	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Blood bilirubin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Gout	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG00237 affected150 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0023 affected150 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Ataxia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Monoplegia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Paraparesis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Mental status changes	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Persistent depressive disorder	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Embolism	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Extremity necrosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected6 at risk EG0011 affected4 at risk EG00247 affected150 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0028 affected150 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Hypothyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG00216 affected150 at risk
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0025 affected150 at risk
Lacrimation increased	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0022 affected150 at risk
Vision blurred	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0026 affected150 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG00219 affected150 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0026 affected150 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Ascites	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00231 affected150 at risk
Dental caries	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected6 at risk EG0010 affected4 at risk EG00232 affected150 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0028 affected150 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG0026 affected150 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0023 affected150 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Melaena	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected6 at risk EG0010 affected4 at risk EG00237 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected6 at risk EG0010 affected4 at risk EG00226 affected150 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG00216 affected150 at risk
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00214 affected150 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected6 at risk EG0012 affected4 at risk EG00261 affected150 at risk
Gait disturbance	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00225 affected150 at risk
Performance status decreased	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected6 at risk EG0011 affected4 at risk EG00229 affected150 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Gingivitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Localised infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0026 affected150 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00212 affected150 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00212 affected150 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0028 affected150 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0022 affected150 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00226 affected150 at risk
Amylase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00213 affected150 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00226 affected150 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00220 affected150 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0028 affected150 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0024 affected150 at risk
Blood uric acid decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00218 affected150 at risk
Lipase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00217 affected150 at risk
Lymphocyte count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0027 affected150 at risk
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0028 affected150 at risk
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00218 affected150 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG00224 affected150 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0028 affected150 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00214 affected150 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00211 affected150 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00212 affected150 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0029 affected150 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0024 affected150 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00214 affected150 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00216 affected150 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk EG00217 affected150 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00223 affected150 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG0025 affected150 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00211 affected150 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG00215 affected150 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0026 affected150 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00215 affected150 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Balance disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Cognitive disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG00213 affected150 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected6 at risk EG0010 affected4 at risk EG00223 affected150 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected150 at risk
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Sinus headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Anxiety	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00211 affected150 at risk
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00211 affected150 at risk
Dysuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0026 affected150 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00233 affected150 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG00226 affected150 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0026 affected150 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0025 affected150 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG00213 affected150 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected150 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk EG00222 affected150 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG00216 affected150 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk EG0029 affected150 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected150 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected150 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hot flush	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected150 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0023 affected150 at risk
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0026 affected150 at risk

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	TRT A	URE3 Q4WK+NIV3 Q2WK
BG001	TRT B	URE8 Q4WK+NIV3 Q2WK
BG002	TRT D	URE8 Q4WK+NIV240mg Q2WK
BG003	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	TRT A	URE3 Q4WK+NIV3 Q2WK	6	6	3	6	6	6
EG001	TRT B	URE8 Q4WK+NIV3 Q2WK	2	4	3	4	4	4
EG002	TRT D	URE8 Q4WK+NIV240mg Q2WK	93	150	86	150	147	150