BMS-936558 (MDX-1106) In Subjects With Advanced/Metastati... | NCT01354431

Name	Class
Ono Pharma USA Inc	INDUSTRY

Label	Type	Intervention Names
Arm 1: nivolumab - 0.3 mg/kg	Experimental	Biological: nivolumab
Arm 2: nivolumab - 2.0 mg/kg	Experimental	Biological: nivolumab
Arm 3: nivolumab - 10.0 mg/kg	Experimental	Biological: nivolumab

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Biological	Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons	Arm 1: nivolumab - 0.3 mg/kg

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.	From randomization to disease progression or death (up to approximately 2 years)

Measure	Description	Time Frame
Best Overall Response Rate (BORR)	BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method

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

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Moores Cancer Center		La Jolla	California	92093	United States
Ucla

PubMed Identifier	Type	Citation	Retractions
27243803	Derived	George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.
25452452

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
FG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W

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

Progression Free Survival (PFS)

PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.

All randomized participants

Posted

Median

80% Confidence Interval

Months

From randomization to disease progression or death (up to approximately 2 years)

ID	Title	Description
OG000	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
OG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W
OG002	Nivolumab 10 mg/kg	Nivolumab 10 mg/kg IV Q3W

Units	Counts
Participants	OG00060 OG00154 OG00254

Title

Denominators

Categories

Title	Measurements
	OG0002.63(1.81 to 3.02) OG0014.11(2.86 to 5.39) OG0024.17(2.79 to 5.49)

Secondary

Best Overall Response Rate (BORR)

BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

80% confidence interval is based on the Clopper and Pearson method

All randomized participants

Posted

Number

80% Confidence Interval

Percent of participants

From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)

ID	Title	Description
OG000	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
OG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W
OG002	Nivolumab 10 mg/kg	Nivolumab 10 mg/kg IV Q3W

Secondary

Overall Survival (OS)

OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up.

OS is based on Kaplan-Meier estimates.

All randomized participants

Posted

Median

80% Confidence Interval

Months

From randomization to to date of death (up to approximately 8 years)

ID	Title	Description
OG000	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
OG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W
OG002	Nivolumab 10 mg/kg	Nivolumab 10 mg/kg IV Q3W

Units	Counts
Participants

Secondary

Number of Participants Experiencing Adverse Events

Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs.

Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days following last dose (up to approximately 6 years)

ID	Title	Description
OG000	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
OG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W
OG002	Nivolumab 10 mg/kg	Nivolumab 10 mg/kg IV Q3W

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0012 affected54 at risk EG0021 affected54 at risk
Neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Acute myocardial infarction	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Atrial fibrillation	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Cardiac failure	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Myocardial ischaemia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Pericardial effusion	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Pericarditis	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Supraventricular tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Adrenal insufficiency	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Goitre	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0022 affected54 at risk
Abdominal pain lower	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Colitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Enterocolitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Gastric haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Gastrointestinal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0021 affected54 at risk
Pancreatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Small intestinal obstruction	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0021 affected54 at risk
Small intestine ulcer	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Death	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Gait disturbance	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
General physical health deterioration	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Influenza like illness	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Localised oedema	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Mucosal inflammation	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Multiple organ dysfunction syndrome	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0021 affected54 at risk
Pain	General disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Cholangitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Cholecystitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Gallbladder obstruction	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Abdominal infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Appendicitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Biliary sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Biliary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Cellulitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Cholecystitis infective	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Klebsiella bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected54 at risk EG0022 affected54 at risk
Pyelonephritis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Skin infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0021 affected54 at risk
Fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Subdural haematoma	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Upper limb fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Blood alkaline phosphatase increased	Investigations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Influenza B virus test positive	Investigations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Liver function test increased	Investigations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Transaminases increased	Investigations	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Dehydration	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0022 affected54 at risk
Failure to thrive	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Hyperkalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Hypophagia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Arthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Flank pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0022 affected54 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0006 affected59 at risk EG0015 affected54 at risk EG0023 affected54 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0022 affected54 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Amnesia	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Ataxia	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Central nervous system lesion	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Cerebrovascular accident	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Depressed level of consciousness	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Dysarthria	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Encephalopathy	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Haemorrhage intracranial	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Headache	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Hemianopia homonymous	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Neuropathy peripheral	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Paraesthesia	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Paralysis recurrent laryngeal nerve	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Partial seizures	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Peripheral motor neuropathy	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Seizure	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Spinal cord compression	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0014 affected54 at risk EG0020 affected54 at risk
Device failure	Product Issues	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Confusional state	Psychiatric disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Mental status changes	Psychiatric disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Acute kidney injury	Renal and urinary disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Haematuria	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Renal failure	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Urinary retention	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Urogenital haemorrhage	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0021 affected54 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0021 affected54 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Knee arthroplasty	Surgical and medical procedures	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Deep vein thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0020 affected54 at risk
Embolism	Vascular disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0020 affected54 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0020 affected54 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0009 affected59 at risk EG0018 affected54 at risk EG0028 affected54 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected54 at risk EG0020 affected54 at risk
Palpitations	Cardiac disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Deafness	Ear and labyrinth disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0025 affected54 at risk
Vision blurred	Eye disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Abdominal distension	Gastrointestinal disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0022 affected54 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0005 affected59 at risk EG0014 affected54 at risk EG0025 affected54 at risk
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0014 affected54 at risk EG0024 affected54 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG00013 affected59 at risk EG00119 affected54 at risk EG00211 affected54 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0009 affected59 at risk EG00110 affected54 at risk EG00216 affected54 at risk
Dry mouth	Gastrointestinal disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0013 affected54 at risk EG0027 affected54 at risk
Dyspepsia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0023 affected54 at risk
Dysphagia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected54 at risk EG0023 affected54 at risk
Flatulence	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0024 affected54 at risk
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00016 affected59 at risk EG00115 affected54 at risk EG00212 affected54 at risk
Stomatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0014 affected54 at risk EG0020 affected54 at risk
Toothache	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG00012 affected59 at risk EG0018 affected54 at risk EG00210 affected54 at risk
Asthenia	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected54 at risk EG0023 affected54 at risk
Chest discomfort	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0024 affected54 at risk
Chest pain	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0013 affected54 at risk EG0021 affected54 at risk
Chills	General disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0015 affected54 at risk EG0027 affected54 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG00025 affected59 at risk EG00125 affected54 at risk EG00229 affected54 at risk
Influenza like illness	General disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0024 affected54 at risk
Mucosal inflammation	General disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Oedema	General disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0021 affected54 at risk
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG00014 affected59 at risk EG00110 affected54 at risk EG00211 affected54 at risk
Pain	General disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0014 affected54 at risk EG0022 affected54 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG0006 affected59 at risk EG0019 affected54 at risk EG0026 affected54 at risk
Hypersensitivity	Immune system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0029 affected54 at risk
Bronchitis	Infections and infestations	24.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Nasopharyngitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Rhinitis	Infections and infestations	24.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected54 at risk EG0021 affected54 at risk
Sinusitis	Infections and infestations	24.0	Systematic Assessment	EG0007 affected59 at risk EG0011 affected54 at risk EG0024 affected54 at risk
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0007 affected59 at risk EG00111 affected54 at risk EG0028 affected54 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0002 affected59 at risk EG0014 affected54 at risk EG0022 affected54 at risk
Contusion	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0003 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Fall	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0022 affected54 at risk
Alanine aminotransferase increased	Investigations	24.0	Systematic Assessment	EG0004 affected59 at risk EG0014 affected54 at risk EG0023 affected54 at risk
Aspartate aminotransferase increased	Investigations	24.0	Systematic Assessment	EG0004 affected59 at risk EG0015 affected54 at risk EG0023 affected54 at risk
Blood alkaline phosphatase increased	Investigations	24.0	Systematic Assessment	EG0001 affected59 at risk EG0011 affected54 at risk EG0025 affected54 at risk
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG0007 affected59 at risk EG0013 affected54 at risk EG0022 affected54 at risk
Weight decreased	Investigations	24.0	Systematic Assessment	EG0009 affected59 at risk EG0017 affected54 at risk EG0029 affected54 at risk
Weight increased	Investigations	24.0	Systematic Assessment	EG0007 affected59 at risk EG0013 affected54 at risk EG0025 affected54 at risk
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0008 affected59 at risk EG00115 affected54 at risk EG00211 affected54 at risk
Dehydration	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0016 affected54 at risk EG0026 affected54 at risk
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0012 affected54 at risk EG0022 affected54 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0017 affected54 at risk EG0025 affected54 at risk
Hyperkalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0015 affected54 at risk EG0025 affected54 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0015 affected54 at risk EG0022 affected54 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00010 affected59 at risk EG00118 affected54 at risk EG00216 affected54 at risk
Arthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0010 affected54 at risk EG0021 affected54 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00012 affected59 at risk EG00117 affected54 at risk EG00217 affected54 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0023 affected54 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0006 affected59 at risk EG0012 affected54 at risk EG0025 affected54 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0018 affected54 at risk EG0025 affected54 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0014 affected54 at risk EG0023 affected54 at risk
Myalgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0009 affected59 at risk EG0015 affected54 at risk EG0029 affected54 at risk
Neck pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0025 affected54 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0005 affected59 at risk EG00116 affected54 at risk EG0025 affected54 at risk
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG0008 affected59 at risk EG0015 affected54 at risk EG0027 affected54 at risk
Dysarthria	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Headache	Nervous system disorders	24.0	Systematic Assessment	EG0007 affected59 at risk EG0016 affected54 at risk EG0029 affected54 at risk
Hypoaesthesia	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0014 affected54 at risk EG0021 affected54 at risk
Neuropathy peripheral	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0025 affected54 at risk
Paraesthesia	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0024 affected54 at risk
Peripheral sensory neuropathy	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0025 affected54 at risk
Taste disorder	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0010 affected54 at risk EG0024 affected54 at risk
Anxiety	Psychiatric disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0014 affected54 at risk EG0024 affected54 at risk
Depression	Psychiatric disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0025 affected54 at risk
Insomnia	Psychiatric disorders	24.0	Systematic Assessment	EG0006 affected59 at risk EG0018 affected54 at risk EG0023 affected54 at risk
Haematuria	Renal and urinary disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Pollakiuria	Renal and urinary disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0012 affected54 at risk EG0022 affected54 at risk
Cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00020 affected59 at risk EG00120 affected54 at risk EG00211 affected54 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0024 affected54 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00015 affected59 at risk EG00111 affected54 at risk EG00210 affected54 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected59 at risk EG0012 affected54 at risk EG0023 affected54 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0005 affected59 at risk EG0013 affected54 at risk EG0022 affected54 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0016 affected54 at risk EG0024 affected54 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0014 affected54 at risk EG0024 affected54 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0012 affected54 at risk EG0022 affected54 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0023 affected54 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0013 affected54 at risk EG0021 affected54 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0013 affected54 at risk EG0020 affected54 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0023 affected54 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0011 affected54 at risk EG0023 affected54 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected59 at risk EG0012 affected54 at risk EG0025 affected54 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0013 affected54 at risk EG0020 affected54 at risk
Dry skin	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0016 affected54 at risk EG00210 affected54 at risk
Erythema	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0010 affected54 at risk EG0023 affected54 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0014 affected54 at risk EG0023 affected54 at risk
Night sweats	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0004 affected59 at risk EG0011 affected54 at risk EG0024 affected54 at risk
Pruritus	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00011 affected59 at risk EG0017 affected54 at risk EG0029 affected54 at risk
Rash	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0008 affected59 at risk EG0016 affected54 at risk EG00212 affected54 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0015 affected54 at risk EG0023 affected54 at risk
Urticaria	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0012 affected54 at risk EG0023 affected54 at risk
Flushing	Vascular disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0014 affected54 at risk EG0023 affected54 at risk
Hot flush	Vascular disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0013 affected54 at risk EG0023 affected54 at risk
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG0003 affected59 at risk EG0013 affected54 at risk EG0024 affected54 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0000 affected59 at risk EG0015 affected54 at risk EG0023 affected54 at risk

ID	Term
D002292	Carcinoma, Renal Cell
D009362	Neoplasm Metastasis

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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	Nivolumab 0.3 mg/kg	Nivolumab 0.3 mg/kg IV Q3W
BG001	Nivolumab 2 mg/kg	Nivolumab 2 mg/kg IV Q3W
BG002	Nivolumab 10 mg/kg	Nivolumab 10 mg/kg IV Q3W
BG003	Total	Total of all reporting groups

ID	Title	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NIVOLUMAB 0.3 mg/kg	51	60	30	59	55	59
EG001	NIVOLUMAB 2 mg/kg	46	54	35	54	54	54
EG002	NIVOLUMAB 10 mg/kg	47	54	24	54	52	54