A Study to Investigate Sitravatinib as Monotherapy and in... | NCT03941873

ID	Type	Description	Link
CTR20182149	Other Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Sitravatinib Monotherapy: 80 mg	Experimental	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Drug: Sitravatinib
Sitravatinib Monotherapy: 120 mg	Experimental	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Drug: Sitravatinib
Sitravatinib 80 mg + Tislelizumab	Experimental	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Drug: Sitravatinib Drug: Tislelizumab
Sitravatinib 120 mg + Tislelizumab	Experimental	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Drug: Sitravatinib Drug: Tislelizumab

Name	Type	Description	Arm Group Labels	Other Names
Sitravatinib	Drug	Administered orally as a capsule	Sitravatinib 120 mg + Tislelizumab Sitravatinib 80 mg + Tislelizumab Sitravatinib Monotherapy: 120 mg

Measure	Description	Time Frame
Number of Participants With Adverse Events	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).	Up to approximately 4 years and 1 month
Objective Response Rate (ORR)	ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.	Up to approximately 4 years and 1 month

Measure	Description	Time Frame
Duration of Response (DOR)	DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Anhui Medical University		Hefei	Anhui	230601	China
Beijing Cancer Hospital

PubMed Identifier	Type	Citation	Retractions
	Result	Zhang, F., et al. Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC). Journal of Clinical Oncology 2022 40:4_suppl, 418; Meeting Abstract, 2022 ASCO Gastrointestinal Cancers Symposium; https://doi.org/10.1200/JCO.2022.40.4_suppl.418
	Result	Chen Z., et al. Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC). Journal of Clinical Oncology 2022 40:4_suppl, 281-281; Meeting Abstract, ASCO Gastrointestinal Cancers Symposium, Abstract 281.

ID	Title	Description
FG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 milligrams (mg) orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer
FG001	Sitravatinib Monotherapy: 120 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 28, 2020	Jan 11, 2024

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

Number of Participants With Adverse Events

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).

The Safety Analysis Set includes all participants who received ≥ 1 dose of any study drug

Posted

Count of Participants

Participants

Up to approximately 4 years and 1 month

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

Units	Counts
Participants	OG0003 OG00124 OG0023 OG003

Title

Denominators

Categories

At least one TEAE

Title	Measurements
	OG0003 OG00124 OG0023 OG003

Primary

Objective Response Rate (ORR)

ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

The Efficacy Evaluable Analysis Set includes all participants who received ≥ 1 dose of any study drug with measurable disease at baseline per RECIST v1.1 and who had ≥ 1 evaluable postbaseline tumor assessment unless treatment was discontinued due to clinical progression or early death (within 13 weeks after the first dose date) before tumor assessment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 4 years and 1 month

ID	Title	Description
OG000	Sitravatinib Monotherapy	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles in participants with anti-programmed cell death protein-1 and anti-PD ligand-1 (PD-1/PD-L1) antibody naïve or refractory/resistant (R/R) HCC
OG001	Sitravatinib + Tislelizumab	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC and anti-PD-1/PD-L1 antibody naïve G/GEJ cancer

Secondary

Duration of Response (DOR)

DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Posted

Median

95% Confidence Interval

Months

Up to approximately 4 years and 1 month

ID	Title	Description
OG000	Sitravatinib Monotherapy	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC
OG001	Sitravatinib + Tislelizumab	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC and anti-PD-1/PD-L1 antibody naïve G/GEJ cancer

Secondary

Disease Control Rate (DCR)

DCR is defined as the percentage of participants with BOR as CR, PR, or stable disease (SD) assessed by investigator per RECIST v1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 4 years and 1 month

ID	Title	Description
OG000	Sitravatinib Monotherapy	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC
OG001	Sitravatinib + Tislelizumab	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC and anti-PD-1/PD-L1 antibody naïve G/GEJ cancer

Units

Secondary

Progression-free Survival (PFS)

PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. Safety analysis set is presented by indication group, as prespecified in the statistical analysis plan.

The Safety Analysis Set includes all participants who received ≥ 1 dose of any study drug

Posted

Median

95% Confidence Interval

Months

Up to approximately 4 years and 1 month

ID	Title	Description
OG000	Sitravatinib Monotherapy	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC
OG001	Sitravatinib + Tislelizumab	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC and anti-PD-1/PD-L1 antibody naïve G/GEJ cancer

Units	Counts
Participants

Secondary

Maximum Plasma Concentration (Cmax) for Sitravatinib

The Sitravatinib Pharmacokinetic (PK) Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms/milliliter (ng/mL)

Predose and up to 24 hours postdose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21) (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab

Secondary

Time to Maximum Plasma Concentration (Tmax) for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Median

Full Range

Hours (h)

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab

Secondary

Clearance After Oral Administration (CL/F) for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters/hour

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab

Secondary

Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab

Secondary

Observed Accumulation Ratio (Ro) for AUC(0-tau) for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

95% Confidence Interval

Ratio

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

Secondary

Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

95% Confidence Interval

Ratio

Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
OG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

Secondary

Plasma Concentrations of Sitravatinib

The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Predose and 6 hours postdose in Cycle 5 Day 1 (21 days in each cycle)

ID	Title	Description
OG000	Sitravatinib Monotherapy	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC
OG001	Sitravatinib + Tislelizumab	Sitravatinib 80 mg or 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with anti-PD-1/PD-L1 antibody naïve or R/R HCC and anti-PD-1/PD-L1 antibody naïve G/GEJ cancer

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypersplenism	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG0030 events0 affected81 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Death	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Septic shock	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Myocardial necrosis marker increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Immune-mediated encephalitis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0019 events5 affected24 at risk EG0021 events1 affected3 at risk EG00335 events22 affected81 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Hypersplenism	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0022 events1 affected3 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0013 events3 affected24 at risk EG0021 events1 affected3 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0014 events4 affected24 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0014 events4 affected24 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected3 at risk EG00127 events14 affected24 at risk EG0020 events0 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected24 at risk EG0021 events1 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Chest discomfort	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected24 at risk EG0021 events1 affected3 at risk EG003
Influenza like illness	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Malaise	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Peripheral swelling	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Portal hypertension	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 events2 affected3 at risk EG00123 events13 affected24 at risk EG0024 events3 affected3 at risk EG003
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 events2 affected3 at risk EG00122 events13 affected24 at risk EG0026 events3 affected3 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0014 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0014 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin unconjugated increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0021 events1 affected3 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood pressure increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
C-reactive protein increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Fibrin D dimer increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0017 events5 affected24 at risk EG0020 events0 affected3 at risk EG003
Myocardial necrosis marker increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected3 at risk EG0013 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected3 at risk EG00113 events10 affected24 at risk EG0020 events0 affected3 at risk EG003
Thyroglobulin decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Thyroxine free decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Urinary occult blood positive	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected3 at risk EG0017 events6 affected24 at risk EG0021 events1 affected3 at risk EG003
White blood cell count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 events1 affected3 at risk EG0015 events4 affected24 at risk EG0020 events0 affected3 at risk EG003
White blood cell count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected24 at risk EG0021 events1 affected3 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0021 events1 affected3 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0014 events3 affected24 at risk EG0020 events0 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0015 events3 affected24 at risk EG0022 events2 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0021 events1 affected3 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0005 events2 affected3 at risk EG0017 events5 affected24 at risk EG0021 events1 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0013 events2 affected24 at risk EG0022 events2 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Vertebral artery occlusion	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Vertebral artery stenosis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected24 at risk EG0020 events0 affected3 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected3 at risk EG00124 events13 affected24 at risk EG0022 events2 affected3 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0017 events5 affected24 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected3 at risk EG00120 events17 affected24 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0014 events2 affected24 at risk EG0020 events0 affected3 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected24 at risk EG0020 events0 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected3 at risk EG00111 events4 affected24 at risk EG0023 events2 affected3 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected24 at risk EG0021 events1 affected3 at risk EG003

ID	Term
D006528	Carcinoma, Hepatocellular
D002277	Carcinoma

ID	Term
D000230	Adenocarcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Title	Description
BG000	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
BG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
BG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
BG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
BG004	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	Sitravatinib Monotherapy: 80 mg	Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	0	3	1	3	3	3
EG001	Sitravatinib Monotherapy: 120 mg	Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	12	24	7	24	24	24
EG002	Sitravatinib 80 mg + Tislelizumab	Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	2	3	2	3	3	3
EG003	Sitravatinib 120 mg + Tislelizumab	Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	53	81	31	81	78	81