A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combin... | NCT03729245

NCT03729245

ID	Type	Description	Link
CA045002	Other Identifier	Bristol-Myers Squibb Protocol ID

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination of bempegaldesleukin + nivolumab	Experimental	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.	Biological: bempegaldesleukin Biological: nivolumab
sunitinib or cabozantinib	Active Comparator	Patients in Arm B will receive the Investigator's choice of either one of two treatment options.	Drug: sunitinib Drug: cabozantinib

Name	Type	Description	Arm Group Labels	Other Names
bempegaldesleukin	Biological	Specified dose on specified days	Combination of bempegaldesleukin + nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC	ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.	Approximately 32 months
Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC	OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.	Approximately 32 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC	Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.	Approximately 32 months

Eligibility Module

Name	Affiliation	Role
Study Director	Nektar Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Urological		Anchorage	Alaska	99503	United States
Western Regional Medical Center - CTCA - PPDS

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38838287	Derived	Tannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S. Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). J Clin Oncol. 2024 Aug 10;42(23):2800-2811. doi: 10.1200/JCO.23.02082. Epub 2024 Jun 5.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w
FG001	Sunitinib or Cabozantinib

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 19, 2021	Feb 13, 2023

Arm/Group Information

ID	Title	Description
BG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w
BG001	Sunitinib or Cabozantinib	Patients in Arm B will receive the Investigator's choice of either one of two treatment options. Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily
BG002	Total	Total of all reporting groups

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
	BG00061.5± 9.74 BG00160.8± 10.24 BG00261.2± 9.99

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00180 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000148 BG001131 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000271 BG001272 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00049 BG00128 BG002

Karnofsky Performance Status (KPS) Score

The Karnofsky Performance Status (KPS) scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities; For example: Score of 100 = Normal, no complaints, no evidence of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 50 = Requires considerable assistance and frequent medical care. 30 = Severely disabled, hospitalization indicated. Death not imminent. 0 = Dead

Number

participants

Title

Denominators

Categories

KPS < 80

Title	Measurements
	BG00077 BG001

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

Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC

ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients.

ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:

NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively
Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively

Posted

Count of Participants

Participants

Approximately 32 months

ID	Title	Description
OG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w
OG001	Sunitinib or Cabozantinib	Patients in Arm B will receive the Investigator's choice of either one of two treatment options. Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily

Units	Counts
Participants	OG000311 OG001312

Title

Denominators

Categories

ORR per mRECIST 1.1 by BICR, ITT All-risk population

- ParticipantsOG000311
- ParticipantsOG001312

Title	Measurements
	OG00073

Primary

Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC

OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.

A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:

NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively
Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively

Posted

Median

95% Confidence Interval

months

Approximately 32 months

ID	Title	Description
OG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w
OG001	Sunitinib or Cabozantinib	Patients in Arm B will receive the Investigator's choice of either one of two treatment options. Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily

Secondary

Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC

Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.

A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:

NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively
Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively

Posted

Median

95% Confidence Interval

Months

Approximately 32 months

ID	Title	Description
OG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w
OG001	Sunitinib or Cabozantinib	Patients in Arm B will receive the Investigator's choice of either one of two treatment options. Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Combination of Bempegaldesleukin + Nivolumab	Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w	109	310	113	310	307	310
EG001	Sunitinib or Cabozantinib	Patients in Arm B will receive the Investigator's choice of either one of two treatment options. Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily	114	306	91	306	304	306

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Corona virus infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG00013 affected310 at risk EG0013 affected306 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0009 affected310 at risk EG0012 affected306 at risk
Pneumonia viral	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG0012 affected306 at risk
Sepsis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG0011 affected306 at risk
Respiratory tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Anal abscess	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Appendicitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Atypical pneumonia	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Cellulitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Diverticulitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Endotoxic shock	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Liver abscess	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Osteomyelitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Parotid abscess	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pharyngitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Postoperative wound infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0012 affected306 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0011 affected306 at risk
Colitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Ascites	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Proctitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG0011 affected306 at risk
Seizure	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0012 affected306 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0013 affected306 at risk
Syncope	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0012 affected306 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Conus medullaris syndrome	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Epilepsy	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hemiplegia	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Radiculopathy	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Sensory disturbance	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Sensory loss	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Speech disorder	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Spinal cord compression	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0007 affected310 at risk EG0012 affected306 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0014 affected306 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0013 affected306 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0012 affected306 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0012 affected306 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG0015 affected306 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0013 affected306 at risk
Renal impairment	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0012 affected306 at risk
Anuria	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hypotension	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0007 affected310 at risk EG0010 affected306 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0012 affected306 at risk
Embolism	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hypertensive crisis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Venous thrombosis	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Fatigue	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Generalised oedema	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Pyrexia	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Asthenia	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Chest pain	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Death	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
General physical health deterioration	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Influenza like illness	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Pain	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Sudden death	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0012 affected306 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0011 affected306 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0011 affected306 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0015 affected306 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0012 affected306 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG0010 affected306 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0012 affected306 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Jaundice	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Blood creatinine increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Ejection fraction decreased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG0010 affected306 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Contrast media allergy	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Contrast media reaction	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Confusional state	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Delirium	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0011 affected306 at risk
Retinal vein occlusion	Eye disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG0010 affected306 at risk
Genital ulceration	Reproductive system and breast disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG0011 affected306 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00087 affected310 at risk EG001161 affected306 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG000100 affected310 at risk EG001119 affected306 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00061 affected310 at risk EG00174 affected306 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00032 affected310 at risk EG00150 affected306 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00030 affected310 at risk EG00149 affected306 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0009 affected310 at risk EG00164 affected306 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00021 affected310 at risk EG00134 affected306 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00014 affected310 at risk EG00135 affected306 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00015 affected310 at risk EG00117 affected306 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0009 affected310 at risk EG00116 affected306 at risk
Fatigue	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00072 affected310 at risk EG00187 affected306 at risk
Pyrexia	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG000121 affected310 at risk EG00128 affected306 at risk
Asthenia	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00077 affected310 at risk EG00157 affected306 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00036 affected310 at risk EG00139 affected306 at risk
Chills	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00045 affected310 at risk EG00127 affected306 at risk
Influenza like illness	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00051 affected310 at risk EG0018 affected306 at risk
Mucosal inflammation	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0008 affected310 at risk EG00139 affected306 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00017 affected310 at risk EG00118 affected306 at risk
Face oedema	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG00017 affected310 at risk EG00113 affected306 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG000105 affected310 at risk EG00133 affected306 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG001113 affected306 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00074 affected310 at risk EG00128 affected306 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00053 affected310 at risk EG00118 affected306 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00024 affected310 at risk EG00133 affected306 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00028 affected310 at risk EG00113 affected306 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00024 affected310 at risk EG0016 affected306 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG00127 affected306 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 affected310 at risk EG00116 affected306 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00017 affected310 at risk EG00171 affected306 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00022 affected310 at risk EG00165 affected306 at risk
Blood creatinine increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00048 affected310 at risk EG00137 affected306 at risk
Weight decreased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00028 affected310 at risk EG00156 affected306 at risk
Lipase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00028 affected310 at risk EG00144 affected306 at risk
Amylase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00014 affected310 at risk EG00140 affected306 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00015 affected310 at risk EG00130 affected306 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00011 affected310 at risk EG00133 affected306 at risk
Platelet count decreased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0001 affected310 at risk EG00141 affected306 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0008 affected310 at risk EG00128 affected306 at risk
Body temperature increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG00034 affected310 at risk EG0011 affected306 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0006 affected310 at risk EG00128 affected306 at risk
Blood pressure increased	Investigations	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG00116 affected306 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00090 affected310 at risk EG00176 affected306 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00053 affected310 at risk EG00157 affected306 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00070 affected310 at risk EG00138 affected306 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00026 affected310 at risk EG00131 affected306 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG00016 affected310 at risk EG00116 affected306 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG00082 affected310 at risk EG001103 affected306 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG00021 affected310 at risk EG00122 affected306 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG00020 affected310 at risk EG00121 affected306 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG00013 affected310 at risk EG00122 affected306 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0005 affected310 at risk EG00116 affected306 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Non-systematic Assessment	EG0004 affected310 at risk EG00117 affected306 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00057 affected310 at risk EG001109 affected306 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00019 affected310 at risk EG00186 affected306 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00082 affected310 at risk EG0013 affected306 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0006 affected310 at risk EG00173 affected306 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 affected310 at risk EG00141 affected306 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0005 affected310 at risk EG00118 affected306 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00087 affected310 at risk EG00190 affected306 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00052 affected310 at risk EG00140 affected306 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00018 affected310 at risk EG00165 affected306 at risk
Hypotonia	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG00016 affected310 at risk EG0011 affected306 at risk
Hypothyroidism	Endocrine disorders	MedDRA (18.1)	Non-systematic Assessment	EG00074 affected310 at risk EG001129 affected306 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (18.1)	Non-systematic Assessment	EG00045 affected310 at risk EG00117 affected306 at risk
Corona virus infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG00036 affected310 at risk EG00137 affected306 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG00014 affected310 at risk EG00116 affected306 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00054 affected310 at risk EG00143 affected306 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00048 affected310 at risk EG00124 affected306 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0006 affected310 at risk EG00117 affected306 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG00017 affected310 at risk EG0012 affected306 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG00029 affected310 at risk EG001112 affected306 at risk
Hypotension	Vascular disorders	MedDRA (18.1)	Non-systematic Assessment	EG00043 affected310 at risk EG0017 affected306 at risk
Insomnia	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG00034 affected310 at risk EG00149 affected306 at risk
Anxiety	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG00026 affected310 at risk EG00131 affected306 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG00015 affected310 at risk EG00118 affected306 at risk
Proteinuria	Renal and urinary disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 affected310 at risk EG00131 affected306 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG00018 affected310 at risk EG0010 affected306 at risk

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
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	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms

ID	Term
C000611752	bempegaldesleukin
D000077210	Sunitinib
D000077594	Nivolumab
C558660	cabozantinib