Study of Cabozantinib in Combination With Atezolizumab Ve... | NCT03755791

NCT03755791

ID	Type	Description	Link
2024-516479-34-00	EU Trial (CTIS) Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental arm	Experimental	Participants with advanced HCC will receive cabozantinib 40 milligrams (mg) oral, once daily (qd) + atezolizumab 1200 mg infusion, once every 3 weeks (q3w)	Drug: Cabozantinib Drug: Atezolizumab
Control arm	Active Comparator	Participants with advanced HCC will receive sorafenib 400 mg twice a day (bid)	Drug: Sorafenib
Single-Agent Cabozantinib arm	Other	Participants with advanced HCC will receive cabozantinib 60 mg qd	Drug: Cabozantinib

Name	Type	Description	Arm Group Labels	Other Names
Cabozantinib	Drug	Supplied as 20-mg tablets; administered orally daily at 40 mg	Experimental arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population	PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	From the date of first participant randomization up to 28 months
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population	OS was defined as the time from randomization to death due to any cause.	From the date of first participant randomization up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population	PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause per RECIST version 1.1.	From the date of first participant randomization up to 28 months

Eligibility Module

Name	Affiliation	Role
Medical Director	Exelixis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Exelixis Clinical Site #208		Phoenix	Arizona	85004	United States
Exelixis Clinical Site #159

PubMed Identifier	Type	Citation	Retractions
38364832	Derived	Yau T, Kaseb A, Cheng AL, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Milwee S, Wang Z, Curran D, Kelley RK, Rimassa L. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): final results of a randomised phase 3 study. Lancet Gastroenterol Hepatol. 2024 Apr;9(4):310-322. doi: 10.1016/S2468-1253(23)00454-5. Epub 2024 Feb 13.
35798016

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental Arm: Cabozantinib + Atezolizumab	Participants received 40 milligrams (mg) cabozantinib oral tablets once daily + 1200 mg intravenous (IV) infusion of atezolizumab once every 3 weeks for up to 38 months.
FG001	Single-Agent 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	Jan 24, 2023	Nov 12, 2025

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) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population

PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

PITT population included the first 372 participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.

Posted

Median

99% Confidence Interval

months

From the date of first participant randomization up to 28 months

ID	Title	Description
OG000	Experimental Arm: Cabozantinib + Atezolizumab	Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
OG001	Control Arm: Sorafenib	Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.

Units	Counts
Participants	OG000250 OG001122

Title

Denominators

Categories

Title	Measurements
	OG0006.80(5.55 to 8.34) OG0014.21(2.79 to 7.03)

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		Log Rank		0.0012		Hazard Ratio (HR)	0.63			2-Sided	99	0.44	0.91					Other

Primary

Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population

OS was defined as the time from randomization to death due to any cause.

ITT population included all participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.

Posted

Mean

96% Confidence Interval

months

From the date of first participant randomization up to 36 months

ID	Title	Description
OG000	Experimental Arm: Cabozantinib + Atezolizumab	Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
OG001	Control Arm: Sorafenib	Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.

Units	Counts
Participants	OG000

Secondary

PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population

PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause per RECIST version 1.1.

ITT population included all participants randomized to the single agent cabozantinib arm and control (sorafenib) arm.

Posted

Median

99% Confidence Interval

months

From the date of first participant randomization up to 28 months

ID	Title	Description
OG000	Single-Agent Cabozantinib	Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
OG001	Control Arm: Sorafenib	Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment		EG0006 affected429 at risk EG0011 affected188 at risk EG0024 affected207 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment		EG0005 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Arrhythmia	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Atrial flutter	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Cardiac arrest	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Cardiac failure	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Cardiogenic shock	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Myocardial infarction	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pericardial effusion	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Tachycardia	Cardiac disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hyperthyroidism	Endocrine disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Thyroiditis	Endocrine disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Visual impairment	Eye disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0008 affected429 at risk EG0014 affected188 at risk EG0024 affected207 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Anal fistula	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Ascites	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG00015 affected429 at risk EG0013 affected188 at risk EG0023 affected207 at risk
Colitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Constipation	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0009 affected429 at risk EG0014 affected188 at risk EG0020 affected207 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Enteritis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Gastritis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0013 affected188 at risk EG0023 affected207 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0012 affected188 at risk EG0021 affected207 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0012 affected188 at risk EG0022 affected207 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0011 affected188 at risk EG0022 affected207 at risk
Visceral venous thrombosis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment		EG0005 affected429 at risk EG0013 affected188 at risk EG0021 affected207 at risk
Abscess sterile	General disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Asthenia	General disorders	MedDRA v23.0	Systematic Assessment		EG0007 affected429 at risk EG0012 affected188 at risk EG0022 affected207 at risk
Chest pain	General disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Death	General disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Fatigue	General disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0012 affected188 at risk EG0021 affected207 at risk
General physical health deterioration	General disorders	MedDRA v23.0	Systematic Assessment		EG0005 affected429 at risk EG0011 affected188 at risk EG0022 affected207 at risk
Generalised oedema	General disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Inflammation	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Influenza like illness	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Malaise	General disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Mucosal inflammation	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Non-cardiac chest pain	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Oedema peripheral	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pyrexia	General disorders	MedDRA v23.0	Systematic Assessment		EG00011 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Sudden death	General disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0012 affected188 at risk EG0021 affected207 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Biloma	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Cholangitis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0008 affected429 at risk EG0014 affected188 at risk EG0022 affected207 at risk
Hepatitis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Jaundice	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Anaphylactic reaction	Immune system disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypersensitivity	Immune system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Abscess limb	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Acute sinusitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Anal abscess	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Appendicitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Biliary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0011 affected188 at risk EG0022 affected207 at risk
Bronchitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
COVID-19	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG00012 affected429 at risk EG0013 affected188 at risk EG0022 affected207 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Cellulitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0022 affected207 at risk
Cholangitis infective	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Cystitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Diverticulitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Endocarditis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Eye infection bacterial	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Gastroenteritis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Groin abscess	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatic infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Klebsiella sepsis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Large intestine infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Localised infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Osteomyelitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Periodontitis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Peritonitis bacterial	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pneumonia	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0007 affected429 at risk EG0014 affected188 at risk EG0023 affected207 at risk
Pneumonia moraxella	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Salmonella bacteraemia	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Sepsis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG00011 affected429 at risk EG0014 affected188 at risk EG0022 affected207 at risk
Septic shock	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Skin infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Soft tissue infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Tooth abscess	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0007 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Urosepsis	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Wound infection	Infections and infestations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatic rupture	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Alanine aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0008 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Amylase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0009 affected429 at risk EG0012 affected188 at risk EG0021 affected207 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Blood bilirubin increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Blood thyroid stimulating hormone abnormal	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Electrocardiogram abnormal	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatic enzyme increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Lipase increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Liver function test abnormal	Investigations	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Liver function test increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Neutrophil count decreased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Platelet count decreased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Transaminases increased	Investigations	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Weight decreased	Investigations	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
White blood cell count decreased	Investigations	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0012 affected188 at risk EG0020 affected207 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0004 affected429 at risk EG0013 affected188 at risk EG0021 affected207 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG00038 affected429 at risk EG00126 affected188 at risk EG00218 affected207 at risk
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0013 affected188 at risk EG0022 affected207 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Brain compression	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Encephalopathy	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Headache	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG00012 affected429 at risk EG0017 affected188 at risk EG0021 affected207 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Parkinson's disease	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Sciatica	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Syncope	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Acute psychosis	Psychiatric disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Confusional state	Psychiatric disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0006 affected429 at risk EG0014 affected188 at risk EG0024 affected207 at risk
Haematuria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Proteinuria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Renal failure	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Renal impairment	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Urinary retention	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA v23.0	Systematic Assessment	This is a gender-specific adverse event that only affects males. So, the number of At Risk participants only includes the total number of male participants.	EG0000 affected360 at risk EG0011 affected158 at risk EG0020 affected186 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Immune-mediated pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0011 affected188 at risk EG0021 affected207 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0008 affected429 at risk EG0012 affected188 at risk EG0021 affected207 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Catheterisation venous	Surgical and medical procedures	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Renal stone removal	Surgical and medical procedures	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Bleeding varicose vein	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Embolism	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0002 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Embolism arterial	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Hypertension	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Hypertensive crisis	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hypotension	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0003 affected429 at risk EG0011 affected188 at risk EG0020 affected207 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Thrombosis	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk
Vena cava thrombosis	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0000 affected429 at risk EG0010 affected188 at risk EG0021 affected207 at risk
Venous thrombosis	Vascular disorders	MedDRA v23.0	Systematic Assessment		EG0001 affected429 at risk EG0010 affected188 at risk EG0020 affected207 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG00055 affected429 at risk EG00123 affected188 at risk EG00224 affected207 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG00037 affected429 at risk EG00116 affected188 at risk EG0027 affected207 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG00043 affected429 at risk EG00122 affected188 at risk EG00211 affected207 at risk
Hypothyroidism	Endocrine disorders	MedDRA v23.0	Systematic Assessment	EG00093 affected429 at risk EG00136 affected188 at risk EG0029 affected207 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00068 affected429 at risk EG00125 affected188 at risk EG00238 affected207 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00035 affected429 at risk EG00120 affected188 at risk EG00217 affected207 at risk
Ascites	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00054 affected429 at risk EG00124 affected188 at risk EG00214 affected207 at risk
Constipation	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00065 affected429 at risk EG00133 affected188 at risk EG00223 affected207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG000215 affected429 at risk EG001102 affected188 at risk EG00298 affected207 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00024 affected429 at risk EG00114 affected188 at risk EG0026 affected207 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00013 affected429 at risk EG00110 affected188 at risk EG0024 affected207 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00070 affected429 at risk EG00140 affected188 at risk EG00230 affected207 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00040 affected429 at risk EG00125 affected188 at risk EG0028 affected207 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00045 affected429 at risk EG00134 affected188 at risk EG00215 affected207 at risk
Asthenia	General disorders	MedDRA v23.0	Systematic Assessment	EG00091 affected429 at risk EG00134 affected188 at risk EG00237 affected207 at risk
Fatigue	General disorders	MedDRA v23.0	Systematic Assessment	EG000113 affected429 at risk EG00160 affected188 at risk EG00236 affected207 at risk
Mucosal inflammation	General disorders	MedDRA v23.0	Systematic Assessment	EG00047 affected429 at risk EG00121 affected188 at risk EG00212 affected207 at risk
Oedema peripheral	General disorders	MedDRA v23.0	Systematic Assessment	EG00053 affected429 at risk EG00122 affected188 at risk EG00215 affected207 at risk
Pyrexia	General disorders	MedDRA v23.0	Systematic Assessment	EG00051 affected429 at risk EG00123 affected188 at risk EG00226 affected207 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG00022 affected429 at risk EG0015 affected188 at risk EG0022 affected207 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG00036 affected429 at risk EG00112 affected188 at risk EG0026 affected207 at risk
Alanine aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG000134 affected429 at risk EG00156 affected188 at risk EG00224 affected207 at risk
Amylase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00037 affected429 at risk EG00111 affected188 at risk EG00210 affected207 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG000138 affected429 at risk EG00161 affected188 at risk EG00230 affected207 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00034 affected429 at risk EG00118 affected188 at risk EG00213 affected207 at risk
Blood bilirubin increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00059 affected429 at risk EG00127 affected188 at risk EG00224 affected207 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00022 affected429 at risk EG0019 affected188 at risk EG0028 affected207 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00022 affected429 at risk EG00116 affected188 at risk EG0022 affected207 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00034 affected429 at risk EG00114 affected188 at risk EG00213 affected207 at risk
Lipase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG00045 affected429 at risk EG0018 affected188 at risk EG00210 affected207 at risk
Neutrophil count decreased	Investigations	MedDRA v23.0	Systematic Assessment	EG00027 affected429 at risk EG00111 affected188 at risk EG0022 affected207 at risk
Platelet count decreased	Investigations	MedDRA v23.0	Systematic Assessment	EG00059 affected429 at risk EG00127 affected188 at risk EG00213 affected207 at risk
Weight decreased	Investigations	MedDRA v23.0	Systematic Assessment	EG00082 affected429 at risk EG00148 affected188 at risk EG00233 affected207 at risk
White blood cell count decreased	Investigations	MedDRA v23.0	Systematic Assessment	EG00016 affected429 at risk EG00111 affected188 at risk EG0024 affected207 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG000128 affected429 at risk EG00181 affected188 at risk EG00243 affected207 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00041 affected429 at risk EG00113 affected188 at risk EG00214 affected207 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00040 affected429 at risk EG00112 affected188 at risk EG00212 affected207 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00026 affected429 at risk EG00113 affected188 at risk EG0023 affected207 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00031 affected429 at risk EG00114 affected188 at risk EG0029 affected207 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00022 affected429 at risk EG00110 affected188 at risk EG0029 affected207 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG00034 affected429 at risk EG00111 affected188 at risk EG00212 affected207 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG00029 affected429 at risk EG0019 affected188 at risk EG00214 affected207 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG00029 affected429 at risk EG00110 affected188 at risk EG0028 affected207 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG00032 affected429 at risk EG0017 affected188 at risk EG0024 affected207 at risk
Dizziness	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG00023 affected429 at risk EG00112 affected188 at risk EG0027 affected207 at risk
Dysgeusia	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG00039 affected429 at risk EG00117 affected188 at risk EG0023 affected207 at risk
Headache	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG00034 affected429 at risk EG00110 affected188 at risk EG0027 affected207 at risk
Insomnia	Psychiatric disorders	MedDRA v23.0	Systematic Assessment	EG00030 affected429 at risk EG00110 affected188 at risk EG0028 affected207 at risk
Proteinuria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG00040 affected429 at risk EG00119 affected188 at risk EG00214 affected207 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG00041 affected429 at risk EG0018 affected188 at risk EG00214 affected207 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG00052 affected429 at risk EG00133 affected188 at risk EG00214 affected207 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG00031 affected429 at risk EG0019 affected188 at risk EG00210 affected207 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG00022 affected429 at risk EG00110 affected188 at risk EG0024 affected207 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG00023 affected429 at risk EG00112 affected188 at risk EG0025 affected207 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG00015 affected429 at risk EG00114 affected188 at risk EG00231 affected207 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG00038 affected429 at risk EG00115 affected188 at risk EG0028 affected207 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG000185 affected429 at risk EG00182 affected188 at risk EG00292 affected207 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG00047 affected429 at risk EG00112 affected188 at risk EG00214 affected207 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG00064 affected429 at risk EG00129 affected188 at risk EG00238 affected207 at risk
Hypertension	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG000106 affected429 at risk EG00156 affected188 at risk EG00239 affected207 at risk

ID	Term
D006528	Carcinoma, Hepatocellular
D009369	Neoplasms
D002277	Carcinoma

ID	Term
D000230	Adenocarcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Experimental Arm: Cabozantinib + Atezolizumab	Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
BG001	Single-Agent Cabozantinib	Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
BG002	Control Arm: Sorafenib	Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental Arm: Cabozantinib + Atezolizumab	Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.	307	429	226	429	414	429
EG001	Single-Agent Cabozantinib	Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.	135	188	88	188	182	188
EG002	Control Arm: Sorafenib	Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.	141	207	85	207	202	207

ID	Term
C558660	cabozantinib
D000077157	Sorafenib
C000594389	atezolizumab