Efficacy and Safety of Tislelizumab in Combination With F... | NCT04716634

ID	Type	Description	Link
CTR20211070	Other Identifier	ChinaDrugTrials

Name	Class
Hutchison Medipharma Limited	INDUSTRY

Label	Type	Description	Intervention Names
Gastric Cancer (GC): Tislelizumab and Fruquintinib	Experimental	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (mg) daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Drug: Tislelizumab Drug: Fruquintinib
Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Experimental	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Drug: Tislelizumab Drug: Fruquintinib
PD-L1 + NSCLC: Tislelizumab and Fruquintinib	Experimental	Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (NSCLC) received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Drug: Tislelizumab Drug: Fruquintinib

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib

Measure	Description	Time Frame
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).	Up to 28 Days
Part 1: Recommended Phase 2 Dose (RP2D)	RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.	Up to 28 Days
Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1	ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)

Measure	Description	Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1	PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (PD) or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Name	Affiliation	Role
Jian Li	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Cancer Hospital		Fuzhou	Fujian	350014	China
The First Hospital of Lanzhou University

ID	Title	Description
FG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (mg) daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 16, 2020	Feb 19, 2025

ID	Title	Description
BG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
BG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
BG002	PD-L1 + NSCLC: Tislelizumab and Fruquintinib	Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00031 BG00131 BG00222 BG00384

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

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).

Analysis was performed on the DLT evaluable analysis set that included all participants in Part 1 who received at least 85% of the assigned total dose of fruquintinib and at least 67% of the assigned total dose of tislelizumab during the DLT assessment period.

Posted

Count of Participants

Participants

Up to 28 Days

ID	Title	Description
OG000	Tislelizumab and Fruquintinib	All participants received the full dose of fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Units	Counts
Participants	OG0006

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Part 1: Recommended Phase 2 Dose (RP2D)

RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.

Analysis was performed on the DLT evaluable analysis set.

Posted

Number

milligrams (mg) per day

Up to 28 Days

ID	Title	Description
OG000	Tislelizumab and Fruquintinib	All participants received the full dose of fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Units	Counts
Participants	OG000

Primary

Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis was performed on the safety analysis set which included all participants who received at least 1 dose of study drug(s).

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib

Secondary

Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1

PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (PD) or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Analysis was performed on the safety analysis set.

Posted

Median

95% Confidence Interval

months

From date of first dose of study drug until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1

DCR was defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by investigator as per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Analysis was performed on the safety analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib

Secondary

Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1

CBR was defined as the percentage of participants whose best overall response is CR, PR, or durable stable disease (SD) as assessed by the investigator per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Analysis was performed on the safety analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib

Secondary

Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1

DOR was defined as the time from the first occurrence of documented objective response to the time of progression as assessed by investigator per RECIST v1.1 or death from any cause, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.

Analysis was performed using participants in the safety analysis set with an objective response.

Posted

Median

95% Confidence Interval

months

From the first objective response to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Overall Survival (OS)

OS was defined as the time from the date of first dose to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

Analysis was performed on the safety analysis set.

Posted

Median

95% Confidence Interval

months

From the first dose of the study treatment to date of death from any cause (up to 2 years and 9 months)

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG002	PD-L1 + NSCLC: Tislelizumab and Fruquintinib

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib

A TEAE was defined as an AE that had an onset date or a worsening in severity from baseline (pre-treatment) on or after the first dose of study drug(s) and up to 30 days following study drug(s) discontinuation or initiation of new anticancer therapy, whichever occurred first determined according to NCI-CTCAE v5.0. Treatment emergent serious Adverse Events (TESAEs): any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator. AEs were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.

Analysis was performed on the safety analysis set.

Posted

Count of Participants

Participants

From the date of the first dose of study drug up to 30 days after the last dose of study drug; up to approximately 2 years and 5 months.

ID	Title	Description
OG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure acute	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Immune-mediated myocarditis	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Myocardial infarction	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Myocardial ischaemia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Ventricular arrhythmia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypopituitarism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
Retinal artery occlusion	Eye disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Ascites	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Diarrhoea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Enterovesical fistula	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gastric haemorrhage	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Impaired gastric emptying	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Intestinal obstruction	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Intestinal perforation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Large intestinal obstruction	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Large intestine perforation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Asthenia	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Death	General disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
General physical health deterioration	General disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0013 events3 affected31 at risk EG0020 events0 affected22 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Biliary obstruction	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Cholecystitis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gallbladder obstruction	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Hepatic function abnormal	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0021 events1 affected22 at risk
Multisystem inflammatory syndrome	Immune system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Biliary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Septic shock	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Blood bilirubin increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Diabetic ketosis	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gingival cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Seizure	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Syncope	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Nephrolithiasis	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Ureterolithiasis	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Prostatic obstruction	Reproductive system and breast disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG00011 events10 affected31 at risk EG0018 events6 affected31 at risk EG0026 events4 affected22 at risk
Coagulopathy	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Leukocytosis	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Lymphadenopathy	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pancytopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Angina pectoris	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Atrioventricular block first degree	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Supraventricular tachycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Ventricular tachycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Tinnitus	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Hyperthyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypophysitis	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Hypopituitarism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0007 events7 affected31 at risk EG00110 events10 affected31 at risk EG0025 events4 affected22 at risk
Thyroid disorder	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Dry eye	Eye disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Abdominal distension	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
Abdominal pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0016 events5 affected31 at risk EG0021 events1 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Angular cheilitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Ascites	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0017 events3 affected31 at risk EG0020 events0 affected22 at risk
Chronic gastritis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Constipation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0023 events3 affected22 at risk
Diarrhoea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected31 at risk EG00115 events10 affected31 at risk EG00212 events4 affected22 at risk
Dry mouth	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Duodenogastric reflux	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Dyspepsia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Eructation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Gingival pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Gingival swelling	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0014 events3 affected31 at risk EG0024 events2 affected22 at risk
Periodontal disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Stomatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0015 events5 affected31 at risk EG0023 events3 affected22 at risk
Toothache	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected31 at risk EG0017 events4 affected31 at risk EG0020 events0 affected22 at risk
Asthenia	General disorders	meddra 26.0	Systematic Assessment	EG00028 events3 affected31 at risk EG0011 events1 affected31 at risk EG0021 events1 affected22 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Chills	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Face oedema	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Fatigue	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0016 events6 affected31 at risk EG0022 events2 affected22 at risk
Influenza like illness	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Malaise	General disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected31 at risk EG0012 events1 affected31 at risk EG0020 events0 affected22 at risk
Non-cardiac chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Oedema peripheral	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pain	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Peripheral swelling	General disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG00112 events6 affected31 at risk EG0025 events3 affected22 at risk
Autoimmune hepatitis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Biliary obstruction	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Cholecystitis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Asymptomatic bacteriuria	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0022 events1 affected22 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected31 at risk EG0023 events3 affected22 at risk
COVID-19 pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
Chronic sinusitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Conjunctivitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Cystitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Gastroenteritis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Gingivitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0022 events1 affected22 at risk
Influenza	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Nasopharyngitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Oral infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Pericoronitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
Pneumonia aspiration	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Pneumonia bacterial	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Rash pustular	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Skin infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Suspected COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events1 affected31 at risk EG0022 events1 affected22 at risk
Upper respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Contusion	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Fall	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Head injury	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Procedural pain	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Skeletal injury	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Thermal burn	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Activated partial thromboplastin time prolonged	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0018 events5 affected31 at risk EG0024 events3 affected22 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events4 affected31 at risk EG00110 events7 affected31 at risk EG0024 events3 affected22 at risk
Bilirubin conjugated increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Blood alkaline phosphatase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0013 events2 affected31 at risk EG0026 events4 affected22 at risk
Blood bilirubin increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0015 events5 affected31 at risk EG0027 events4 affected22 at risk
Blood bilirubin unconjugated increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Blood chloride decreased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Blood cholesterol increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Blood corticotrophin decreased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Blood creatine phosphokinase MB increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0025 events3 affected22 at risk
Blood creatine phosphokinase increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Blood creatinine increased	Investigations	meddra 26.0	Systematic Assessment	EG0005 events3 affected31 at risk EG0011 events1 affected31 at risk EG0026 events2 affected22 at risk
Blood fibrinogen decreased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Blood glucose increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Blood lactate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0024 events3 affected22 at risk
Blood thyroid stimulating hormone increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events2 affected31 at risk EG0012 events2 affected31 at risk EG0025 events3 affected22 at risk
Blood uric acid increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Gamma-glutamyltransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0013 events2 affected31 at risk EG0024 events2 affected22 at risk
Lymphocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Myocardial necrosis marker increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00014 events5 affected31 at risk EG00110 events2 affected31 at risk EG0024 events3 affected22 at risk
Neutrophil count increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Occult blood positive	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Platelet count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00010 events5 affected31 at risk EG0016 events3 affected31 at risk EG0026 events4 affected22 at risk
Protein total decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Protein urine present	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
SARS-CoV-2 test positive	Investigations	meddra 26.0	Systematic Assessment	EG0008 events3 affected31 at risk EG0011 events1 affected31 at risk EG0023 events3 affected22 at risk
Urinary occult blood positive	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Urobilinogen urine increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Weight decreased	Investigations	meddra 26.0	Systematic Assessment	EG00012 events11 affected31 at risk EG0013 events3 affected31 at risk EG0023 events3 affected22 at risk
Weight increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00023 events7 affected31 at risk EG0012 events1 affected31 at risk EG0022 events2 affected22 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected31 at risk EG0019 events6 affected31 at risk EG0025 events4 affected22 at risk
Diabetes mellitus	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0022 events2 affected22 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Hyperglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events1 affected31 at risk EG0023 events2 affected22 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0022 events1 affected22 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hyperuricaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0023 events1 affected22 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00014 events10 affected31 at risk EG0014 events4 affected31 at risk EG00213 events9 affected22 at risk
Hypocalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Hypochloraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00015 events6 affected31 at risk EG0010 events0 affected31 at risk EG00210 events3 affected22 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected31 at risk EG0011 events1 affected31 at risk EG0024 events4 affected22 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0003 events1 affected31 at risk EG0011 events1 affected31 at risk EG0021 events1 affected22 at risk
Hypovolaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0013 events2 affected31 at risk EG0022 events2 affected22 at risk
Arthritis	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected31 at risk EG0012 events2 affected31 at risk EG0021 events1 affected22 at risk
Bone pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Flank pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Myalgia	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0005 events1 affected31 at risk EG0014 events3 affected31 at risk EG0021 events1 affected22 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Altered state of consciousness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Cerebral infarction	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Dizziness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0023 events1 affected22 at risk
Headache	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0013 events3 affected31 at risk EG0022 events2 affected22 at risk
Hypoaesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Paraesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Somnolence	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Transient ischaemic attack	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Tremor	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Anxiety	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Insomnia	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Albuminuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Dysuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Haematuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0011 events1 affected31 at risk EG0025 events3 affected22 at risk
Proteinuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0007 events7 affected31 at risk EG00118 events13 affected31 at risk EG00217 events7 affected22 at risk
Urethritis noninfective	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Gynaecomastia	Reproductive system and breast disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pelvic pain	Reproductive system and breast disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0013 events2 affected31 at risk EG0020 events0 affected22 at risk
Prostatic obstruction	Reproductive system and breast disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Uterine disorder	Reproductive system and breast disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0026 events6 affected22 at risk
Diaphragmatic spasm	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0012 events2 affected31 at risk EG0021 events1 affected22 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0021 events1 affected22 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0023 events2 affected22 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0012 events2 affected31 at risk EG0020 events0 affected22 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Eczema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Erythema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0010 events0 affected31 at risk EG0020 events0 affected22 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG00110 events7 affected31 at risk EG0023 events3 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0013 events2 affected31 at risk EG0024 events3 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected31 at risk EG0011 events1 affected31 at risk EG0022 events2 affected22 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk EG0021 events1 affected22 at risk
Hypertension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0007 events7 affected31 at risk EG0016 events6 affected31 at risk EG0025 events5 affected22 at risk
Hypotension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk EG0020 events0 affected22 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gastric Cancer (GC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	24	31	13	31	28	31
EG001	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib	Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	24	31	14	31	29	31
EG002	PD-L1 + NSCLC: Tislelizumab and Fruquintinib	Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	8	22	13	22	19	22