A Single-Arm, Open-Label, Multicenter Clinical Trial With... | NCT02156804

NCT02156804

ID	Type	Description	Link
2014-001286-28	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Nivolumab (BMS-936558)	Experimental	Nivolumab (BMS-936558) Intravenous solution every 2 weeks	Drug: Nivolumab (BMS-936558)

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab (BMS-936558)	Drug		Nivolumab (BMS-936558)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.	The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events	The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.	Up to 2 years
Median Time to Onset (Grades 3-4) of Select Adverse Events

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Graz		8036	Austria
Local Institution

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31581055	Derived	Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.
31445199

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

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
SAP	No	Yes	No	Statistical Analysis Plan	Jun 13, 2019	Jan 10, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.1± 13.84

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000451
Male	BG000557

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00027
Not Hispanic or Latino	BG000972

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0003

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.

The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.

All treated participants

Posted

Number

Number of Participants

Up to 2 years

ID	Title	Description
OG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG0001008

Title

Denominators

Categories

Gastrointestinal Adverse events (Grade 3-4)

Title	Measurements
	OG00016

Gastrointestinal adverse events (Grade 5)

Title	Measurements
	OG0000

Hepatic adverse events (Grade 3-4)

Secondary

The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events

The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.

All treated Participants

Posted

Number

Number of Participants

Up to 2 years

ID	Title	Description
OG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG0001008

Secondary

Median Time to Onset (Grades 3-4) of Select Adverse Events

Select AEs were summarized according to their incidence as well as their time to onset.

All Treated Participants.

Posted

Median

Full Range

Weeks

Up to 2 years.

ID	Title	Description
OG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG0001008

Secondary

Median Time to Resolution (Grades 3-4) of Select Adverse Events

Select AEs were summarized according to their incidence as well as their time to resolution

All Treated Participants

Posted

Median

Full Range

Weeks

Up to 2 years

ID	Title	Description
OG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG0001008

Secondary

Overall Survival

The time from first dosing date to the date of death.

All Treated Participants

Posted

Median

95% Confidence Interval

Months

Up to 4 years

ID	Title	Description
OG000	Nivolumab 3mg/kg	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG0001008

Title	Denominators

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG00010 affected1,008 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Myocarditis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Addison's disease	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hypophysitis	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Hypopituitarism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Lymphocytic hypophysitis	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Steroid withdrawal syndrome	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ectropion	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Iridocyclitis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Iritis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Macular hole	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ulcerative keratitis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Uveitis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vision blurred	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00013 affected1,008 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Autoimmune colitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Autoimmune pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,008 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected1,008 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Intussusception	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Melaena	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00010 affected1,008 at risk
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Disease progression	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,008 at risk
General physical health deterioration	General disorders	MedDRA 21.1	Systematic Assessment	EG00022 affected1,008 at risk
Generalised oedema	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Malaise	General disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Nodule	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,008 at risk
Sudden death	General disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Treatment failure	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Jaundice	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Anaphylactic shock	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Autoimmune disorder	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Contrast media allergy	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Abdominal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Abdominal sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Anal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Appendiceal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Arthritis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0006 affected1,008 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Cystitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Device related infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Device related sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Erysipelas	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0007 affected1,008 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Haematoma infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Herpes zoster	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Infected dermal cyst	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Infected lymphocele	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Latent tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0009 affected1,008 at risk
Lung infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Perirectal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00013 affected1,008 at risk
Pneumonia legionella	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Septic encephalopathy	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Soft tissue infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tonsillitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tooth abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Tooth infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00011 affected1,008 at risk
Urosepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Vascular device infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Viral diarrhoea	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Viral infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Wound infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Dose calculation error	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Radiation necrosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Blood creatinine increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
CSF test abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
General physical condition abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
International normalised ratio increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lipase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Pancreatic enzymes increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Transaminases increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Troponin T increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,008 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected1,008 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Anal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Malignant neoplasm of spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG000278 affected1,008 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Metastases to bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00016 affected1,008 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastases to skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0005 affected1,008 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00015 affected1,008 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Aphasia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Brachial plexopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Brain injury	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Brain oedema	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,008 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Epilepsy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Facial paresis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Hemiparesis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Miller Fisher syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Narcolepsy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Nervous system disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Peripheral nerve lesion	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Polyneuropathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected1,008 at risk
Sensorimotor disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Spinal cord compression	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Status epilepticus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Device dislocation	Product Issues	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Confusional state	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Personality change	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Schizophrenia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,008 at risk
Autoimmune nephritis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Bladder pain	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Postrenal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Penile oedema	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Testicular oedema	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,008 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,008 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00010 affected1,008 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00014 affected1,008 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Angiopathy	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Embolism	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Extremity necrosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,008 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lymphoedema	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,008 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vascular occlusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Retinal detachment	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Subileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,008 at risk
Pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Meningitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Septic shock	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lethargy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Neurological decompensation	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Sciatica	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Respiratory muscle weakness	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk
Lymphocele	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,008 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG000126 affected1,008 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG000114 affected1,008 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG000102 affected1,008 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00058 affected1,008 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG000132 affected1,008 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG000210 affected1,008 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG000212 affected1,008 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG000120 affected1,008 at risk
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment	EG000168 affected1,008 at risk
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG000295 affected1,008 at risk
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG00081 affected1,008 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG000130 affected1,008 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00088 affected1,008 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00054 affected1,008 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG00083 affected1,008 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG00078 affected1,008 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG00052 affected1,008 at risk
Lipase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG00079 affected1,008 at risk
Weight decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG00063 affected1,008 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG000143 affected1,008 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG000148 affected1,008 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG000116 affected1,008 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00055 affected1,008 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00062 affected1,008 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00093 affected1,008 at risk
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG000122 affected1,008 at risk
Insomnia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG00055 affected1,008 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG000134 affected1,008 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00081 affected1,008 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00054 affected1,008 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG000115 affected1,008 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00089 affected1,008 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00054 affected1,008 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00077 affected1,008 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00051 affected1,008 at risk

Title

Denominators

Categories

Gastrointestinal Adverse events (Grade 3-4)

Title	Measurements
	OG00024

Gastrointestinal adverse events (Grade 5)

Title	Measurements
	OG0000

Hepatic adverse events (Grade 3-4)

Title	Measurements
	OG00052

Hepatic adverse events (Grade 5)

Title	Measurements
	OG0001

Pulmonary adverse events(Grade 3-4)

Title	Measurements
	OG0007

Pulmonary adverse events(Grade 5)

Title	Measurements
	OG0001

Renal adverse events (Grade 3-4)

Title	Measurements
	OG00012

Renal adverse events (Grade 5)

Title	Measurements
	OG0001

Skin adverse events ( Grade 3-4)

Title	Measurements
	OG00019

Skin adverse events ( Grade 5)

Title	Measurements
	OG0000

Hypersensitivity adverse event( Grade 3-4)

Title	Measurements
	OG0002

Hypersensitivity adverse event( Grade 5)

Title	Measurements
	OG0000

Endocrine adverse events(Grade 3-4)

Title	Measurements
	OG00024

Endocrine adverse events(Grade 5)

Title	Measurements
	OG0000

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins