A Study of Nivolumab Safety and Pharmacokinetics in Patie... | NCT02960854

Label	Type	Description	Intervention Names
Nivolumab 1	Experimental	Dose 1	Biological: Nivolumab
Nivolumab 2	Experimental	Dose 2	Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab 1 Nivolumab 2

Measure	Description	Time Frame
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths		Screening, day -1, day 1 and subsequent days after, up to 90 days
Composite of Vital Signs and Electrocardiogram (ECG)	Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.	Screening up to 90 days (Discharge)
Peak Nivolumab Serum Concentration (Cmax)	Participants peak nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Trough Nivolumab Serum Concentration (Cmin)	Participant trough nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Average Nivolumab Serum Concentration (Cavg)	Participant average nivolumab serum concentration	Day 1 and subsequent days after, up to 90 days
Time of Maximum Observed Concentration (Tmax)	Participant observed time of maximum concentration	Day 1 and subsequent days after, up to 90 days
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration

Measure	Description	Time Frame
Receptor Occupancy	Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points	Day 1 and up to day 90 (discharge)
Number of Participants With Detectable Anti-nivolumab Antibodies

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

Facility	Status	City	State	ZIP	Country	Contacts
Uc Davis Medical Center		Sacramento	California	95817	United States
Univ. Of Colorado Health

PubMed Identifier	Type	Citation	Retractions
31576433	Derived	Hotchkiss RS, Colston E, Yende S, Crouser ED, Martin GS, Albertson T, Bartz RR, Brakenridge SC, Delano MJ, Park PK, Donnino MW, Tidswell M, Mayr FB, Angus DC, Coopersmith CM, Moldawer LL, Catlett IM, Girgis IG, Ye J, Grasela DM. Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of nivolumab. Intensive Care Med. 2019 Oct;45(10):1360-1371. doi: 10.1007/s00134-019-05704-z. Epub 2019 Oct 1.

Label	URL
BMS Clinical Trial Patient Recruiting	View source

ID	Title	Description
FG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
FG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 17, 2017	Jan 5, 2019

ID	Title	Description
BG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
BG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00015 BG00116 BG00231

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

Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths

All treated participants

Posted

Number

Percentage

Screening, day -1, day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG00015 OG00116

Title

Denominators

Categories

Serious Adverse Events (SAEs)

Title	Measurements
	OG0006.7 OG00143.8

Adverse Events (AEs)

Title	Measurements
	OG000

Primary

Composite of Vital Signs and Electrocardiogram (ECG)

Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.

All treated participants

Posted

Mean

Standard Deviation

Percentage

Screening up to 90 days (Discharge)

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Peak Nivolumab Serum Concentration (Cmax)

Participants peak nivolumab serum concentration

All Treated participants

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Trough Nivolumab Serum Concentration (Cmin)

Participant trough nivolumab serum concentration

All treated participants

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Average Nivolumab Serum Concentration (Cavg)

Participant average nivolumab serum concentration

All treated participants

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Time of Maximum Observed Concentration (Tmax)

Participant observed time of maximum concentration

All Treated participants

Posted

Median

Full Range

hours

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration

All Treated Participants

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Total Clearance (CLT)

Total clearance of serum concentration of nivolumab

All Treated Participants

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Volume of Distribution (Vd)

Vlume of distribution of nivolumab serum concentration

All Treated Participants

Posted

Geometric Mean

Geometric Coefficient of Variation

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Primary

Half-life (T1/2)

Half-Life of nivolumab derived from serum concentration

All Treated Participants

Posted

Mean

Standard Deviation

hours

Day 1 and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Secondary

Receptor Occupancy

Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points

All Treated Participants

Posted

Mean

Standard Deviation

Percentage

Day 1 and up to day 90 (discharge)

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Secondary

Number of Participants With Detectable Anti-nivolumab Antibodies

Participant with positive anti-drug antibody detection

All Treated Participants

Posted

Number

Percentage

Baseline and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Secondary

Number of Participants With Any Detectable Anti-drug Antibodies

All Treated Participants

Posted

Number

Percentage

Baseline and subsequent days after, up to 90 days

ID	Title	Description
OG000	Nivolumab (480 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg
OG001	Nivolumab (960 mg)	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected15 at risk EG0018 affected16 at risk
Bandaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0014 affected16 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Bundle branch block right	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Cardiomegaly	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Mastoid effusion	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Corneal epithelium defect	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Macular degeneration	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Periorbital oedema	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Pupils unequal	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected15 at risk EG0012 affected16 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected16 at risk
Flatulence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected15 at risk EG0012 affected16 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected15 at risk EG0012 affected16 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Catheter site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Catheter site haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Face oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Generalised oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0012 affected16 at risk
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected15 at risk EG0016 affected16 at risk
Secretion discharge	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Porcelain gallbladder	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Abdominal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Candida infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Genital infection fungal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Herpes dermatitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Herpes simplex	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Impetigo	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Oral candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Purulent discharge	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Tracheitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Viral tracheitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Stoma site discharge	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Ammonia increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Amylase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Bacterial test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Blood bilirubin abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Blood bilirubin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Blood glucose increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Blood potassium increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Brain natriuretic peptide increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Breath sounds abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Bronchoalveolar lavage abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
C-reactive protein increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Chest x-ray abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Clostridium test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Ejection fraction decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Fungal test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Gastric ph increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Herpes simplex test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
International normalised ratio increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Lipase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Liver function test abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Oxygen saturation decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Reticulocyte count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Sputum culture positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Staphylococcus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Transaminases increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Urine output decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
White blood cell count increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected16 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0013 affected16 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected15 at risk EG0014 affected16 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected16 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0014 affected16 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Muscle necrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected16 at risk
Facial paresis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Intensive care unit acquired weakness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Lethargy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Thrombosis in device	Product Issues	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Agitation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected16 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0012 affected16 at risk
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected16 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Nightmare	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Oliguria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Polyuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0014 affected16 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected16 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected15 at risk EG0015 affected16 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0012 affected16 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected16 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected16 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0014 affected16 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected16 at risk
Dry gangrene	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Extremity necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected16 at risk
Flushing	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected16 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected15 at risk EG0014 affected16 at risk
Labile blood pressure	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected16 at risk

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NIVOLUMAB 480mg	the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	4	15	1	15	14	15
EG001	NIVOLUMAB 960mg	the assessment of the safety and tolerability of a single dose of nivolumab 960 mg	6	16	7	16	14	16