A Study Investigating the Efficacy and Safety of Ociperli... | NCT04948697

ID	Type	Description	Link
CTR20211546	Registry Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Arm A: Ociperlimab + Tislelizumab + BAT1706	Experimental	Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Drug: Ociperlimab Drug: Tislelizumab Drug: BAT1706
Arm B: Tislelizumab + BAT1706	Experimental	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Drug: Tislelizumab Drug: BAT1706

Name	Type	Description	Arm Group Labels	Other Names
Ociperlimab	Drug	900 mg intravenously once every 3 weeks (dosed in 21-day cycles)	Arm A: Ociperlimab + Tislelizumab + BAT1706

Measure	Description	Time Frame
Objective Response Rate (ORR) as Assessed by the Investigator	ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (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 less than (<) 10 millimeters (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.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

Measure	Description	Time Frame
Duration Of Response (DOR) as Assessed by the Investigator	DOR was defined as the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease or death whichever comes first, assessed based on RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease 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
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100021	China
Beijing Cancer Hospital

PubMed Identifier	Type	Citation	Retractions
42047833	Derived	Ren Z, Huang Y, Guo Y, Hou MM, Wang W, Kuang M, Hao C, Wang W, Zhang Y, Song T, Dai C, Kuo HT, Bao Z, Zuo Y, Wang L, Zhu F, Fan J. AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma. Cancer Immunol Immunother. 2026 Apr 28;75(5):158. doi: 10.1007/s00262-026-04399-8.

ID	Title	Description
FG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles 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	Mar 3, 2021	Jan 30, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR) as Assessed by the Investigator

ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (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 less than (<) 10 millimeters (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.

Analysis was performed on the Intent-to-Treat (ITT) analysis set that included all randomized participants and were analyzed according to their randomized treatment arm (i.e., Arm A or Arm B).

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Units	Counts
Participants	OG00062 OG00132

Title

Denominators

Categories

Title	Measurements
	OG00037.1(25.2 to 50.3) OG00140.6(23.7 to 59.4)

Secondary

Duration Of Response (DOR) as Assessed by the Investigator

DOR was defined as the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease or death whichever comes first, assessed based on RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease 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 participants in the ITT analysis set with an objective response.

Posted

Median

95% Confidence Interval

months

From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Time to Response (TTR) as Assessed by the Investigator

TTR was defined as the time from the randomization date to the date of first documented partial response (PR) or better by the investigator, assessed based on RECIST v1.1. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis was performed on participants in the ITT analysis set with an objective response.

Posted

Median

Full Range

months

From the randomization date to the first documentation of response (up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Disease Control Rate (DCR) as Assessed by the Investigator

DCR was defined as the percentage of participants who achieve complete response (CR), partial response (PR) or stable disease (SD), assessed based on 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 ITT analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Clinical Benefit Rate (CBR) as Assessed by the Investigator

CBR was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as >= 24 weeks). Per RECIST 1.1., 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.

Analysis was performed on ITT analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Progression-Free Survival (PFS) as Assessed by the Investigator

PFS was evaluated by the investigator according to RECIST version 1.1; and was defined as the time from the randomization date to the date of first documentation of disease progression or date of death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v 1.1, progressive disease 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 ITT analysis set.

Posted

Median

95% Confidence Interval

months

From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles 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 randomization date until the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.

Analysis was performed on ITT analysis set.

Posted

Median

95% Confidence Interval

months

From the randomization date until the date of death from any cause (up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Units	Counts
Participants

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A TEAE was defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) and up to 30 days after the last dose of study drug(s), or initiation of new anticancer therapy, whichever occurs first. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0, 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 safety analysis set that included all participants of each arm who received at least 1 dose of study drugs.

Posted

Count of Participants

Participants

From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706

Secondary

Serum Concentrations of Ociperlimab

Serum samples were assayed for ociperlimab concentrations using a validated immunoassay. This outcome measure was not analyzed for Arm B as ociperlimab was not administered in Arm B.

Analysis was performed on Pharmacokinetics (PK) analysis set that included all participants who received at least 1 dose of any component of study drugs as per the protocol, and for whom any post dose PK data was available. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit.

Posted

Mean

Standard Deviation

micrograms per milliliters (mcg/mL)

Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Units	Counts
Participants

Secondary

Serum Concentrations of Tislelizumab

Serum samples were assayed for tislelizumab concentrations using a validated immunoassay.

Analysis was performed on PK analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit.

Posted

Mean

Standard Deviation

micrograms per milliliters (mcg/mL)

Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Serum Concentrations of BAT1706

Serum samples were assayed for BAT1706 concentrations using a validated immunoassay.

Analysis was performed on PK analysis set. Here, "number analyzed" signifies participants with available data for each specified category at respective visit.

Posted

Mean

Standard Deviation

micrograms per milliliters (mcg/mL)

Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
OG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

Secondary

Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706

Serum samples were tested for the presence of ADAs to ociperlimab, tislelizumab and BAT1706 using a validated immunoassay. The analysis included: Treatment-emergent ADA: sum of treatment-boosted ADA patients and treatment-induced ADA participants as a percentage of the ADA-evaluable participants population; Treatment-boosted ADA: Baseline-positive ADA-evaluable patients with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period; and Treatment-induced ADA: ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period.

Analysis was performed on the Immunogenicity analysis set that included all participants who received at least 1 dose of any component of study drugs and for whom both baseline ADA and >=1 post-baseline ADA result was available. Here, "0" in the number analyzed field signifies that participants in Arm B were not assessed for anti-ociperlimab ADAs since they did not receive ociperlimab.

Posted

Count of Participants

Participants

Up to 27 months

ID	Title	Description
OG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles 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
Angina unstable	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Myocardial injury	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Thyroiditis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Enteritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Subileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Upper gastrointestinal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Haemobilia	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Abdominal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Biliary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected31 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Laryngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Peritonitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Peritonsillitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0012 events2 affected31 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Skin infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Scrotal inflammation	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected31 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	EG00020 events13 affected62 at risk EG0015 events4 affected31 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events2 affected62 at risk EG0010 events0 affected31 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected31 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected62 at risk EG0014 events4 affected31 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Bundle branch block right	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected31 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Myocardial injury	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected31 at risk
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected31 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected31 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected62 at risk EG0016 events2 affected31 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected31 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected62 at risk EG0019 events9 affected31 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Glaucoma	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Refraction disorder	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0011 events1 affected31 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected62 at risk EG0014 events3 affected31 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected62 at risk EG0013 events2 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00012 events10 affected62 at risk EG00113 events10 affected31 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected31 at risk
Flatulence	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected31 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0014 events3 affected31 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Loose tooth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0011 events1 affected31 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0011 events1 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected62 at risk EG0012 events2 affected31 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0012 events1 affected31 at risk
Chest discomfort	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 events8 affected62 at risk EG0013 events3 affected31 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0012 events2 affected31 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected62 at risk EG0015 events5 affected31 at risk
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00026 events13 affected62 at risk EG0016 events4 affected31 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected31 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected31 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00034 events12 affected62 at risk EG0016 events6 affected31 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Gingivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0012 events2 affected31 at risk
Otitis media	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Periodontitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0014 events2 affected31 at risk
Pharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Pulpitis dental	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected31 at risk
Rhinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected62 at risk EG0013 events3 affected31 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected62 at risk EG0010 events0 affected31 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Procedural dizziness	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00040 events23 affected62 at risk EG00115 events8 affected31 at risk
Androgens abnormal	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00049 events26 affected62 at risk EG00113 events9 affected31 at risk
Bile acids increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected31 at risk
Bilirubin conjugated increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events2 affected31 at risk
Bilirubin urine present	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00017 events10 affected62 at risk EG0011 events1 affected31 at risk
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00017 events10 affected62 at risk EG00112 events8 affected31 at risk
Blood corticotrophin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0013 events2 affected31 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00016 events7 affected62 at risk EG0015 events2 affected31 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected62 at risk EG0011 events1 affected31 at risk
Blood fibrinogen increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0010 events0 affected31 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00017 events6 affected62 at risk EG0012 events2 affected31 at risk
Blood pressure increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0012 events1 affected31 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Blood urea increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Cortisol decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Cortisol increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected62 at risk EG0012 events2 affected31 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected62 at risk EG0011 events1 affected31 at risk
Glucose urine present	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
International normalised ratio increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Myocardial necrosis marker increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0006 events4 affected62 at risk EG0013 events2 affected31 at risk
Neutrophil count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected31 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00059 events23 affected62 at risk EG00115 events8 affected31 at risk
Platelet count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Protein urine present	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events2 affected62 at risk EG0011 events1 affected31 at risk
Prothrombin time prolonged	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0013 events3 affected31 at risk
Troponin I increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Troponin T increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Troponin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Urinary occult blood positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Urobilinogen urine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected62 at risk EG0014 events4 affected31 at risk
Weight increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events2 affected62 at risk EG0012 events2 affected31 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00017 events9 affected62 at risk EG0014 events3 affected31 at risk
White blood cell count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0011 events1 affected31 at risk
White blood cells urine positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00011 events9 affected62 at risk EG0015 events5 affected31 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0011 events1 affected31 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0010 events0 affected31 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected62 at risk EG0011 events1 affected31 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected62 at risk EG0014 events2 affected31 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00022 events11 affected62 at risk EG0013 events2 affected31 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00017 events12 affected62 at risk EG00116 events10 affected31 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0006 events3 affected62 at risk EG0010 events0 affected31 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00013 events10 affected62 at risk EG0018 events4 affected31 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected62 at risk EG0017 events3 affected31 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected62 at risk EG0010 events0 affected31 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected62 at risk EG0010 events0 affected31 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected62 at risk EG0011 events1 affected31 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected62 at risk EG0011 events1 affected31 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0012 events1 affected31 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Lacunar infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected62 at risk EG0014 events3 affected31 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0013 events3 affected31 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Proteinuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00036 events24 affected62 at risk EG00129 events16 affected31 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected31 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected31 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events6 affected62 at risk EG0011 events1 affected31 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected31 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected31 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected62 at risk EG0010 events0 affected31 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0011 events1 affected31 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected31 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected62 at risk EG0010 events0 affected31 at risk
Immune-mediated dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected31 at risk
Leukoderma	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected62 at risk EG0010 events0 affected31 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00015 events13 affected62 at risk EG0012 events2 affected31 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00017 events15 affected62 at risk EG0017 events6 affected31 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected31 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected31 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00034 events23 affected62 at risk EG00119 events15 affected31 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
BG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
BG002	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	Arm A: Ociperlimab + Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	28	62	31	62	61	62
EG001	Arm B: Tislelizumab + BAT1706	Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	14	32	12	31	31	31