CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With P... | NCT03428217

Status Module

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
Pbo-Cabo	Placebo Comparator	Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.	Drug: Cabozantinib Drug: Placebo
CB-Cabo	Experimental	CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.	Drug: CB-839 Drug: Cabozantinib

Name	Type	Description	Arm Group Labels	Other Names
CB-839	Drug	Oral glutaminase inhibitor	CB-Cabo	telaglenastat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)	PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause. Estimated from Kaplan-Meier methodology. 95% confidence interval (CI) based on Brookmeyer-Crowley methodology.	Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.

Eligibility Module

Name	Affiliation	Role
Sam Whiting, M.D., Ph.D.	Calithera Biosciences, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Mayo Clinic Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36048457	Derived	Tannir NM, Agarwal N, Porta C, Lawrence NJ, Motzer R, McGregor B, Lee RJ, Jain RK, Davis N, Appleman LJ, Goodman O Jr, Stadler WM, Gandhi S, Geynisman DM, Iacovelli R, Mellado B, Sepulveda Sanchez JM, Figlin R, Powles T, Akella L, Orford K, Escudier B. Efficacy and Safety of Telaglenastat Plus Cabozantinib vs Placebo Plus Cabozantinib in Patients With Advanced Renal Cell Carcinoma: The CANTATA Randomized Clinical Trial. JAMA Oncol. 2022 Oct 1;8(10):1411-1418. doi: 10.1001/jamaoncol.2022.3511.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pbo-Cabo	Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
FG001

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	Apr 9, 2020	Jan 23, 2023

Masking Info

Arm/Group Information

ID	Title	Description
BG000	Pbo-Cabo	Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
BG001	CB-Cabo	CB-839 800 mg BID + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
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
	BG00061.7± 10.33 BG00160.6± 10.37 BG00261.2± 10.36

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00068 BG00147 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00014 BG00111 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000176 BG001174 BG002

Stratification Factor: Prior PD-1/PD-L1 Inhibitor Therapy

PD-1: programmed cell death protein 1 PD-L1: programmed cell death protein ligand 1

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG000139 BG001137

Stratification Factor: IMDC Category

The International Metastatic renal cell carcinoma Database Consortium (IMDC) score is currently used as prognostic index to stratify patients with mRCC in 3 subgroups: good/favorable, intermediate and poor-risk groups.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Poor	BG00035 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

Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)

PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria:

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Intent-to-Treat (ITT) Analysis Set: All randomized participants, analyzed according to the treatment group to which they are randomized.

Posted

Median

95% Confidence Interval

months

Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months.

ID	Title	Description
OG000	Pbo-Cabo	Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
OG001	CB-Cabo	CB-839 800 mg BID + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.

Units	Counts
Participants	OG000223 OG001221

Title

Denominators

Categories

Title	Measurements
	OG0009.33(7.64 to 11.01) OG0019.17(7.59 to 11.10)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).	Log Rank		0.6528		Hazard Ratio (HR)	0.94			2-Sided	95	0.74	1.21					Superiority

Secondary

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause. Estimated from Kaplan-Meier methodology. 95% confidence interval (CI) based on Brookmeyer-Crowley methodology.

ITT Analysis Set: All randomized participants, analyzed according to the treatment group to which they are randomized.

Posted

Median

95% Confidence Interval

months

Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.

ID	Title	Description
OG000	Pbo-Cabo	Placebo BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
OG001	CB-Cabo	CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.

Units	Counts
Participants

Secondary

PFS as Assessed by the Investigator

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

ITT Analysis Set: All randomized participants, analyzed according to the treatment group to which they are randomized.

Posted

Median

95% Confidence Interval

months

Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.64 months.

ID	Title	Description
OG000	Pbo-Cabo	Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
OG001

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	Pbo-Cabo	Placebo BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.	89	223	74	217	213	217
EG001	CB-Cabo	CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.	93	221	90	225	222	225

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Embolism	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Haemorrhage	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Thrombophlebitis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Nerve block	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Metastases to pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Pregnancy of partner	Social circumstances	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected225 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Chills	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Death	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Malaise	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Mucosal inflammation	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Confusional state	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0012 affected225 at risk
Delirium	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Troponin I increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0007 affected217 at risk EG0015 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0014 affected225 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0015 affected225 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected225 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected225 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Aphasia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Dyskinesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Monoplegia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Motor dysfunction	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Spinal cord compression	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0016 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0013 affected225 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected225 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected225 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Melaena	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Volvulus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected217 at risk EG0011 affected225 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected217 at risk EG0012 affected225 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected217 at risk EG0012 affected225 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0013 affected225 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected217 at risk EG0012 affected225 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected225 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 affected217 at risk EG0012 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 affected217 at risk EG0011 affected225 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected225 at risk
Abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Anal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected225 at risk
Tooth infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected225 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Appendicitis perforated	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Cholecystitis infective	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Encephalitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Joint abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Paraspinal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Soft tissue infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk
Wound abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected225 at risk
Wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected225 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG00072 affected217 at risk EG00182 affected225 at risk
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG00013 affected217 at risk EG00110 affected225 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG000109 affected217 at risk EG00194 affected225 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG00049 affected217 at risk EG00149 affected225 at risk
Mucosal inflammation	General disorders	MedDRA 23.1	Systematic Assessment	EG00036 affected217 at risk EG00123 affected225 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG00021 affected217 at risk EG00122 affected225 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG00015 affected217 at risk EG00120 affected225 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG00013 affected217 at risk EG0019 affected225 at risk
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG00017 affected217 at risk EG00121 affected225 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG00012 affected217 at risk EG00116 affected225 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG00016 affected217 at risk EG0017 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG00012 affected217 at risk EG00111 affected225 at risk
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG00065 affected217 at risk EG00177 affected225 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00039 affected217 at risk EG00163 affected225 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00040 affected217 at risk EG00156 affected225 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00012 affected217 at risk EG00124 affected225 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00014 affected217 at risk EG00115 affected225 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00041 affected217 at risk EG00150 affected225 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00041 affected217 at risk EG00133 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00034 affected217 at risk EG00130 affected225 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00016 affected217 at risk EG00120 affected225 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00013 affected217 at risk EG00121 affected225 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00029 affected217 at risk EG00128 affected225 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00014 affected217 at risk EG00120 affected225 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00052 affected217 at risk EG00141 affected225 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00032 affected217 at risk EG00139 affected225 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00024 affected217 at risk EG00123 affected225 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00012 affected217 at risk EG00110 affected225 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00014 affected217 at risk EG00122 affected225 at risk
Photophobia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0008 affected217 at risk EG00126 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000160 affected217 at risk EG001162 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000118 affected217 at risk EG001123 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00075 affected217 at risk EG00177 affected225 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00063 affected217 at risk EG00169 affected225 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00049 affected217 at risk EG00147 affected225 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00039 affected217 at risk EG00140 affected225 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00024 affected217 at risk EG00142 affected225 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00028 affected217 at risk EG00135 affected225 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00025 affected217 at risk EG00121 affected225 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00021 affected217 at risk EG00114 affected225 at risk
Oral pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00015 affected217 at risk EG0019 affected225 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0009 affected217 at risk EG00114 affected225 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG00017 affected217 at risk EG00128 affected225 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00087 affected217 at risk EG00195 affected225 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00028 affected217 at risk EG00140 affected225 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00020 affected217 at risk EG00125 affected225 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00019 affected217 at risk EG00119 affected225 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00015 affected217 at risk EG00116 affected225 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00011 affected217 at risk EG00120 affected225 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00014 affected217 at risk EG00113 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00037 affected217 at risk EG00143 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00033 affected217 at risk EG00133 affected225 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00027 affected217 at risk EG00128 affected225 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00024 affected217 at risk EG00129 affected225 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00019 affected217 at risk EG00111 affected225 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00013 affected217 at risk EG00114 affected225 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0009 affected217 at risk EG00115 affected225 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG00056 affected217 at risk EG00166 affected225 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00086 affected217 at risk EG00183 affected225 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00049 affected217 at risk EG00148 affected225 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00038 affected217 at risk EG00132 affected225 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00027 affected217 at risk EG00125 affected225 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00030 affected217 at risk EG00116 affected225 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00026 affected217 at risk EG00118 affected225 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00016 affected217 at risk EG00114 affected225 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00013 affected217 at risk EG00115 affected225 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00014 affected217 at risk EG00112 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00018 affected217 at risk EG00123 affected225 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00012 affected217 at risk EG00120 affected225 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

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms