An Investigational Immuno-therapy Study of Nivolumab, Com... | NCT02632409

NCT02632409

ID	Type	Description	Link
2014-003626-40	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
Nivolumab	Experimental	Nivolumab dose as specified	Biological: Nivolumab
Placebo	Placebo Comparator	Placebo dose as specified	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological		Nivolumab
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Free Survival (DFS)	The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.	approximately up to 48 months
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population	The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.	approximately up to 48 months

Secondary Outcomes

Measure	Description	Time Frame
Non-Urothelial Tract Recurrence Free Survival	The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.	up to 53 months
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Urological Institute dba Alaska Clinical Research Center		Anchorage	Alaska	99503	United States

PubMed Identifier	Type	Citation	Retractions
40775055	Derived	Galsky MD, Bajorin DF, Tomita Y, Ye D, Agerbaek M, Enting D, Peer A, Milowsky M, Kobayashi K, Grimm MO, Stenner F, David JM, Li J, Chasalow SD, Nasroulah F, Apfel A, Unsal-Kacmaz K, Necchi A. Adjuvant nivolumab in muscle-invasive urothelial carcinoma: exploratory biomarker analysis of the randomized phase 3 CheckMate 274 trial. Nat Med. 2025 Sep;31(9):3062-3073. doi: 10.1038/s41591-025-03802-8. Epub 2025 Aug 7.
40204616

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Placebo
FG001	Nivolumab	Nivolumab 240mg IV Q2W

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 18, 2019	Jul 16, 2021

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

Disease Free Survival (DFS)

The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

approximately up to 48 months

ID	Title	Description
OG000	Placebo	Placebo
OG001	Nivolumab	Nivolumab 240mg IV Q2W

Units	Counts
Participants	OG000356 OG001353

Title

Denominators

Categories

Title	Measurements
	OG00010.84(8.25 to 13.86) OG00120.76(16.49 to 27.63)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Cox Proportional hazard model		0.0008		Hazard Ratio (HR)	0.70			2-Sided	98.22	0.55	0.90					Superiority

Primary

Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population

All Randomized Participants with PD-L1 expression ≥ 1%

Posted

Median

95% Confidence Interval

Months

approximately up to 48 months

ID	Title	Description
OG000	Placebo	Placebo
OG001	Nivolumab	Nivolumab 240mg IV Q2W

Units	Counts
Participants	OG000

Secondary

Non-Urothelial Tract Recurrence Free Survival

The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

up to 53 months

ID	Title	Description
OG000	Placebo	Placebo
OG001	Nivolumab	Nivolumab 240mg IV Q2W

Units	Counts
Participants	OG000

Secondary

Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population

The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

All Randomized Participants with PD-L1 expression ≥ 1%

Posted

Median

95% Confidence Interval

Months

up to 53 months

ID	Title	Description
OG000	Placebo	Placebo
OG001	Nivolumab	Nivolumab 240mg IV Q2W

Units	Counts
Participants	OG000

Secondary

Overall Survival

the time from randomization to the date of death from any cause.

Not Posted

Jan 2026

on going

Participants

Secondary

Overall Survival in Participants With PD-L1 Expression ≥ 1%

the time from randomization to the date of death from any cause.

Not Posted

Jan 2026

on going

Participants

Secondary

Disease Specific Survival

the time from randomization to the date of death due to disease (urothelial cancer).

Not Posted

Jan 2026

on going

Participants

Secondary

Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%

the time from randomization to the date of death due to disease (urothelial cancer).

Not Posted

Jan 2026

on going

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Bone marrow failure	Blood and lymphatic system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Febrile neutropenia	Blood and lymphatic system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Neutropenia	Blood and lymphatic system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Arteriosclerosis coronary artery	Cardiac disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Atrial fibrillation	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0013 affected351 at risk
Atrioventricular block	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Atrioventricular block complete	Cardiac disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Cardiac failure	Cardiac disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Cardiac failure congestive	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Coronary artery disease	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0013 affected351 at risk
Coronary artery stenosis	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Immune-mediated myocarditis	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Myocardial infarction	Cardiac disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Myocarditis	Cardiac disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Vertigo	Ear and labyrinth disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Adrenal insufficiency	Endocrine disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Hyperparathyroidism	Endocrine disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Ocular hypertension	Eye disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Colitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG0014 affected351 at risk
Colitis ischaemic	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Diarrhoea	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0013 affected351 at risk
Duodenitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Enterocele	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Enterovesical fistula	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Ileus	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Intestinal obstruction	Gastrointestinal disorders	23.0	Systematic Assessment	EG0006 affected348 at risk EG0015 affected351 at risk
Nausea	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Necrotising oesophagitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Pancreatitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG0011 affected351 at risk
Pouchitis	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Small intestinal obstruction	Gastrointestinal disorders	23.0	Systematic Assessment	EG0005 affected348 at risk EG0011 affected351 at risk
Subileus	Gastrointestinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Umbilical hernia	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Vomiting	Gastrointestinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Catheter site extravasation	General disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Complication associated with device	General disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Fatigue	General disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Generalised oedema	General disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Multiple organ dysfunction syndrome	General disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Non-cardiac chest pain	General disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Pain	General disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Pyrexia	General disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0013 affected351 at risk
Sudden death	General disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG0011 affected351 at risk
Bile duct stone	Hepatobiliary disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Cholecystitis	Hepatobiliary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0013 affected351 at risk
Drug-induced liver injury	Hepatobiliary disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Hepatic function abnormal	Hepatobiliary disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Hepatitis	Hepatobiliary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Abscess limb	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Appendicitis	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Bacteraemia	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0012 affected351 at risk
Bronchiolitis	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Cellulitis	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Chest wall abscess	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Citrobacter sepsis	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Device related infection	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Diverticulitis	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Erysipelas	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Escherichia sepsis	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Escherichia urinary tract infection	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Gastroenteritis	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Infected lymphocele	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Infection	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Influenza	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Klebsiella infection	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Lower respiratory tract infection	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Penile infection	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Peritonitis	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Pneumonia	Infections and infestations	23.0	Systematic Assessment	EG0005 affected348 at risk EG0011 affected351 at risk
Pyelonephritis	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0011 affected351 at risk
Pyelonephritis acute	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0011 affected351 at risk
Respiratory tract infection viral	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Sepsis	Infections and infestations	23.0	Systematic Assessment	EG0004 affected348 at risk EG0015 affected351 at risk
Septic encephalopathy	Infections and infestations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Septic shock	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Skin infection	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Soft tissue infection	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Urinary tract infection	Infections and infestations	23.0	Systematic Assessment	EG00021 affected348 at risk EG00112 affected351 at risk
Urinary tract infection bacterial	Infections and infestations	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Urosepsis	Infections and infestations	23.0	Systematic Assessment	EG0009 affected348 at risk EG0013 affected351 at risk
Wound infection	Infections and infestations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Hand fracture	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Hypobarism	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Incisional hernia	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0013 affected351 at risk
Infusion related reaction	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0012 affected351 at risk
Overdose	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Pelvic fracture	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Penetrating abdominal trauma	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Stab wound	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Stoma site erythema	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Subdural haematoma	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Urinary tract stoma complication	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Urostomy complication	Injury, poisoning and procedural complications	23.0	Systematic Assessment	EG0001 affected348 at risk EG0012 affected351 at risk
Alanine aminotransferase increased	Investigations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Amylase increased	Investigations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Aspartate aminotransferase increased	Investigations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Blood alkaline phosphatase increased	Investigations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Blood bilirubin increased	Investigations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Blood magnesium decreased	Investigations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Clostridium test positive	Investigations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Lipase increased	Investigations	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Platelet count decreased	Investigations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Transaminases increased	Investigations	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Dehydration	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Hypercalcaemia	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Hyperglycaemia	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Hyperkalaemia	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0012 affected351 at risk
Malnutrition	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Osteitis	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG00039 affected348 at risk EG00115 affected351 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Recurrent cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0002 affected348 at risk EG0012 affected351 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Urinary tract carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Cerebral infarction	Nervous system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Cerebrovascular accident	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Demyelination	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Dizziness	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Embolic stroke	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Haemorrhage intracranial	Nervous system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Ischaemic cerebral infarction	Nervous system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Myasthenia gravis	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Seizure	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Subarachnoid haemorrhage	Nervous system disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Syncope	Nervous system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Transient ischaemic attack	Nervous system disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Device malfunction	Product Issues	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Acute kidney injury	Renal and urinary disorders	23.0	Systematic Assessment	EG0003 affected348 at risk EG0016 affected351 at risk
Autoimmune nephritis	Renal and urinary disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Haematuria	Renal and urinary disorders	23.0	Systematic Assessment	EG0003 affected348 at risk EG0010 affected351 at risk
Hydronephrosis	Renal and urinary disorders	23.0	Systematic Assessment	EG0004 affected348 at risk EG0013 affected351 at risk
Nephrolithiasis	Renal and urinary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Pyelocaliectasis	Renal and urinary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Renal failure	Renal and urinary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Ureteric stenosis	Renal and urinary disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Urinary retention	Renal and urinary disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Urinary tract obstruction	Renal and urinary disorders	23.0	Systematic Assessment	EG0005 affected348 at risk EG0013 affected351 at risk
Pelvic fluid collection	Reproductive system and breast disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Immune-mediated pneumonitis	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0012 affected351 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0016 affected351 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0013 affected351 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Rash	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0011 affected351 at risk
Aortic aneurysm	Vascular disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Aortic rupture	Vascular disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Deep vein thrombosis	Vascular disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG0010 affected351 at risk
Hypotension	Vascular disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Peripheral ischaemia	Vascular disorders	23.0	Systematic Assessment	EG0000 affected348 at risk EG0011 affected351 at risk
Venous thrombosis limb	Vascular disorders	23.0	Systematic Assessment	EG0001 affected348 at risk EG0010 affected351 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	23.0	Systematic Assessment	EG00041 affected348 at risk EG00153 affected351 at risk
Hyperthyroidism	Endocrine disorders	23.0	Systematic Assessment	EG0004 affected348 at risk EG00137 affected351 at risk
Hypothyroidism	Endocrine disorders	23.0	Systematic Assessment	EG0009 affected348 at risk EG00141 affected351 at risk
Abdominal pain	Gastrointestinal disorders	23.0	Systematic Assessment	EG00042 affected348 at risk EG00137 affected351 at risk
Constipation	Gastrointestinal disorders	23.0	Systematic Assessment	EG00057 affected348 at risk EG00150 affected351 at risk
Diarrhoea	Gastrointestinal disorders	23.0	Systematic Assessment	EG00092 affected348 at risk EG001105 affected351 at risk
Dry mouth	Gastrointestinal disorders	23.0	Systematic Assessment	EG0002 affected348 at risk EG00120 affected351 at risk
Nausea	Gastrointestinal disorders	23.0	Systematic Assessment	EG00052 affected348 at risk EG00163 affected351 at risk
Vomiting	Gastrointestinal disorders	23.0	Systematic Assessment	EG00031 affected348 at risk EG00131 affected351 at risk
Asthenia	General disorders	23.0	Systematic Assessment	EG00031 affected348 at risk EG00142 affected351 at risk
Fatigue	General disorders	23.0	Systematic Assessment	EG00089 affected348 at risk EG00199 affected351 at risk
Oedema peripheral	General disorders	23.0	Systematic Assessment	EG00026 affected348 at risk EG00132 affected351 at risk
Pyrexia	General disorders	23.0	Systematic Assessment	EG00040 affected348 at risk EG00137 affected351 at risk
Nasopharyngitis	Infections and infestations	23.0	Systematic Assessment	EG00025 affected348 at risk EG00123 affected351 at risk
Upper respiratory tract infection	Infections and infestations	23.0	Systematic Assessment	EG00026 affected348 at risk EG00131 affected351 at risk
Urinary tract infection	Infections and infestations	23.0	Systematic Assessment	EG00055 affected348 at risk EG00168 affected351 at risk
Alanine aminotransferase increased	Investigations	23.0	Systematic Assessment	EG00017 affected348 at risk EG00123 affected351 at risk
Amylase increased	Investigations	23.0	Systematic Assessment	EG00029 affected348 at risk EG00146 affected351 at risk
Aspartate aminotransferase increased	Investigations	23.0	Systematic Assessment	EG00017 affected348 at risk EG00119 affected351 at risk
Blood alkaline phosphatase increased	Investigations	23.0	Systematic Assessment	EG0009 affected348 at risk EG00118 affected351 at risk
Blood creatinine increased	Investigations	23.0	Systematic Assessment	EG00049 affected348 at risk EG00151 affected351 at risk
Lipase increased	Investigations	23.0	Systematic Assessment	EG00030 affected348 at risk EG00140 affected351 at risk
Decreased appetite	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG00030 affected348 at risk EG00149 affected351 at risk
Hyperglycaemia	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG00025 affected348 at risk EG00119 affected351 at risk
Hyperkalaemia	Metabolism and nutrition disorders	23.0	Systematic Assessment	EG00026 affected348 at risk EG00121 affected351 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG00045 affected348 at risk EG00140 affected351 at risk
Back pain	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG00044 affected348 at risk EG00147 affected351 at risk
Myalgia	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG00012 affected348 at risk EG00122 affected351 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	23.0	Systematic Assessment	EG00021 affected348 at risk EG00124 affected351 at risk
Dizziness	Nervous system disorders	23.0	Systematic Assessment	EG00029 affected348 at risk EG00132 affected351 at risk
Headache	Nervous system disorders	23.0	Systematic Assessment	EG00030 affected348 at risk EG00133 affected351 at risk
Insomnia	Psychiatric disorders	23.0	Systematic Assessment	EG00017 affected348 at risk EG00124 affected351 at risk
Cough	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG00039 affected348 at risk EG00148 affected351 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	23.0	Systematic Assessment	EG00021 affected348 at risk EG00142 affected351 at risk
Dry skin	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG00016 affected348 at risk EG00125 affected351 at risk
Pruritus	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG00056 affected348 at risk EG001107 affected351 at risk
Rash	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG00036 affected348 at risk EG00167 affected351 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	23.0	Systematic Assessment	EG0009 affected348 at risk EG00122 affected351 at risk
Hypertension	Vascular disorders	23.0	Systematic Assessment	EG00019 affected348 at risk EG00116 affected351 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	Placebo	Placebo
BG001	Nivolumab	Nivolumab 240mg IV Q2W
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo	0	0	129	348	307	348
EG001	Nivolumab	Nivolumab 240mg IV Q2W	0	0	122	351	332	351